pharmacovigilance specialist

MSD Türkiye

<div>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 At our company, we are dedicated to advancing the prevention and treatment of diseases in people and animals through innovative health solutions. As a premier research-intensive biopharmaceutical company, we are seeking a passionate and detail-oriented Pharmacovigilance Specialist to join our team. This role offers the opportunity to contribute to our mission of saving and improving lives around the world through leading-edge science.
 <br/>
 <br/>
 <strong>
  How You&rsquo;ll Make An Impact
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Conduct PV Intake activities, including reconciliation and follow-up to ensure patient safety.
  </li>
  <li>
   Perform individual case safety report (ICSR) and aggregate submissions for comprehensive safety monitoring.
  </li>
  <li>
   Support audits and inspections, ensuring readiness and compliance.
  </li>
  <li>
   Author local SOPs and drive local training initiatives.
  </li>
  <li>
   Escalate safety issues promptly and manage archiving with precision.
  </li>
  <li>
   Participate in additional activities and impactful projects overseen by your manager.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Required
  <br/>
  <br/>
 </strong>
 <strong>
  What You Bring to the Team
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Physician/pharmacist degree or equivalent by education/experience.
  </li>
  <li>
   Fluency in English and proficiency in Turkish.
  </li>
  <li>
   General knowledge of PV regulations within the assigned country.
  </li>
  <li>
   Expertise in PV processes and activities.
  </li>
  <li>
   Strong communication and time management skills.
  </li>
  <li>
   Ability to prioritize assignments and work independently with minimal supervision.
  </li>
  <li>
   Proficiency in Microsoft Office (Word, Excel, PowerPoint, etc.).
  </li>
  <li>
   Capability to learn new computer interface systems and familiarity with safety databases.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Required Skills
  <br/>
  <br/>
 </strong>
 Adverse Event Report, Communication, Computer Literacy, Detail-Oriented, Microsoft Office, Pharmacovigilance, Regulatory Compliance
 <br/>
 <br/>
 <strong>
  Preferred Skills
  <br/>
  <br/>
 </strong>
 Current Employees apply HERE
 <br/>
 <br/>
 Current Contingent Workers apply HERE
 <br/>
 <br/>
 <strong>
  Search Firm Representatives Please Read Carefully
  <br/>
  <br/>
 </strong>
 Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
 <br/>
 <br/>
 <strong>
  Employee Status
  <br/>
  <br/>
 </strong>
 Regular
 <br/>
 <br/>
 <strong>
  Relocation
  <br/>
  <br/>
 </strong>
 <strong>
  VISA Sponsorship
  <br/>
  <br/>
 </strong>
 <strong>
  Travel Requirements
  <br/>
  <br/>
 </strong>
 <strong>
  Flexible Work Arrangements
  <br/>
  <br/>
 </strong>
 Hybrid
 <br/>
 <br/>
 <strong>
  Shift
  <br/>
  <br/>
 </strong>
 <strong>
  Valid Driving License
  <br/>
  <br/>
 </strong>
 <strong>
  Hazardous Material(s)
  <br/>
  <br/>
 </strong>
 <strong>
  Job Posting End Date
  <br/>
  <br/>
 </strong>
 05/12/2026
 <br/>
 <br/>
 <ul>
  <li>
   A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Requisition ID
 </strong>
 R395467
</div>


Pharmacovigilance Specialist

<div><p>Job Description</p><p></p><p>
At our company, we are dedicated to advancing the prevention and treatment of diseases in people and animals through innovative health solutions. As a premier research-intensive biopharmaceutical company, we are seeking a passionate and detail-oriented Pharmacovigilance Specialist to join our team. This role offers the opportunity to contribute to our mission of saving and improving lives around the world through leading-edge science.</p><p></p><p><b>
How You&rsquo;ll Make an Impact</b></p><ul><li><p>
Conduct PV Intake activities, including reconciliation and follow-up to ensure patient safety.</p></li><li><p>
Perform individual case safety report (ICSR) and aggregate submissions for comprehensive safety monitoring.</p></li><li><p>
Support audits and inspections, ensuring readiness and compliance.</p></li><li><p>
Author local SOPs and drive local training initiatives.</p></li><li><p>
Escalate safety issues promptly and manage archiving with precision.</p></li><li><p>
Participate in additional activities and impactful projects overseen by your manager.</p></li></ul><p></p><p><b>
What You Bring to the Team</b></p><p><i>
Required</i></p><ul><li><p>
Physician/pharmacist degree or equivalent by education/experience.</p></li><li><p>
Fluency in English and proficiency in Turkish.</p></li><li><p>
General knowledge of PV regulations within the assigned country.</p></li><li><p>
Expertise in PV processes and activities.</p></li><li><p>
Strong communication and time management skills.</p></li><li><p>
Ability to prioritize assignments and work independently with minimal supervision.</p></li><li><p>
Proficiency in Microsoft Office (Word, Excel, PowerPoint, etc.).</p></li><li><p>
Capability to learn new computer interface systems and familiarity with safety databases.</p></li></ul><p></p><p><b>
Required Skills:
</b></p>Adverse Event Report, Communication, Computer Literacy, Detail-Oriented, Microsoft Office, Pharmacovigilance, Regulatory Compliance<p></p><p><b>
Preferred Skills:
</b></p><p></p><p>Current Employees apply HERE</p><p></p><p>
Current Contingent Workers apply HERE</p><p></p><p><b>
Search Firm Representatives Please Read Carefully</b><br>
Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.</p><p></p><p><b>
Employee Status:
</b></p>Regular<p></p><p><b>
Relocation:</b></p><p></p><p><b>
VISA Sponsorship:</b></p><p></p><p><b>
Travel Requirements:</b></p><p></p><p><b>
Flexible Work Arrangements:</b></p>
Hybrid<p></p><p><b>
Shift:</b></p><p></p><p><b>
Valid Driving License:</b></p><p></p><p><b>
Hazardous Material(s):</b></p><p></p><p><b>
Job Posting End Date:</b></p>
05/12/2026<ul><li><b>A job posting is effective until 11:59:59PM on the day </b><b>BEFORE</b><b> the listed job posting end date. Please ensure you apply to a job posting no later than the day </b><b>BEFORE</b><b> the job posting end date.<br>
</b></li></ul><br>
<p><b>Requisition ID:</b>R395467</p></div>

IQVIA

<div>Durham, United States of America | Full time | Home-based | R1538058</div>
<br><div><h2 class="jobSectionHeader"><b>Safety Specialist &ndash; FSP Team at IQVIA</b></h2><div>
Step into a role where your attention to detail, passion for patient safety, and drive for excellence truly make an impact. The FSP team at IQVIA is looking for a dynamic <b>Safety Specialist</b> ready to grow, collaborate, and help deliver high‑quality pharmacovigilance support for global clients. If you thrive in a fast‑paced environment and love the idea of contributing to safer healthcare outcomes, this is your moment.</div><h3 class="jobSectionHeader"><b>
What You&rsquo;ll Do</b></h3><div>
You&rsquo;ll be at the heart of our safety operations, ensuring that every case is handled with precision, speed, and care. Your responsibilities will include:</div><ul><li><div><b>
Processing non‑serious adverse event cases</b> with accuracy and efficiency.</div></li><li><div><b>
Entering and transferring data</b> from AE forms in solicited programs into <b>ARGUS</b>, following a <b>local affiliate model</b> rather than a centralized ARGUS setup.</div></li><li><div>
Collaborating closely with the <b>case processing team</b>, who will finalize cases in ARGUS, perform medical coding, and generate regulatory‑ready reports.</div></li><li><div>
Supporting the timely submission of safety reports to the <b>FDA and other global regulatory authorities</b>.</div></li></ul><h3 class="jobSectionHeader"><b>
What You Bring</b></h3><div>
We&rsquo;re looking for someone who&rsquo;s ready to jump in and contribute from day one:</div><ul><li><div><b>
1&ndash;3 years of experience</b> in Safety or Pharmacovigilance.</div></li><li><div>
A solid understanding of <b>case processing workflows</b> and safety database operations.</div></li><li><div>
Familiarity with <b>ARGUS</b> or similar safety systems.</div></li><li><div>
A commitment to quality, timelines, and continuous improvement.</div></li><li><div>
A proactive, positive mindset and the ability to thrive in a collaborative team environment.</div></li></ul><h3 class="jobSectionHeader"><b>
Why Join IQVIA&rsquo;s FSP Team</b></h3><div>
You&rsquo;ll be part of a global organization that&rsquo;s shaping the future of healthcare through data, technology, and human expertise. In this role, you&rsquo;ll gain exposure to diverse projects, supportive leadership, and opportunities to grow your skills in a high‑impact area of clinical safety.</div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div>
The potential base pay range for this role, when annualized, is $50,100.00 - $125,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</div>

Safety Specialist

Merck

<div><p><b>Job Description</b></p><p></p><p>
The primary purpose of this position is to handle adverse drug events (ADE&rsquo;s) and technical product inquiries reported into the business unit. In addition, this position may be involved in tracking complaints and developing trend analysis reports, reviewing and approving cases, and training new hires on products, and pharmacovigilance/compliance procedures.</p><p>
Pharmacovigilance Veterinarians are based remotely/home office. Schedule is Monday through Friday, 40 hours a week. Expected work hours are 9-6 pm EST.</p><p></p><p><b><br>
MAJOR ACTIVITIES AND RESPONSIBILITIES</b></p><ul><li><p>
Handle adverse drug events reported into the business unit &ndash;40%</p></li><li><p>
Communicate with our company Animal Health customers (primarily via telephone and email) to help resolve medical issues with patients experiencing adverse reactions or efficacy issues with Our Company's Companion Animal products.</p></li><li><p>
Document and enter complaints into the database in accordance with government and corporate policies and procedures.</p></li><li><p>
Initiate product quality testing procedures when applicable.</p></li><li><p>
Facilitate and consult on diagnostics.</p></li><li><p>
Process product efficacy guarantee requests.</p></li><li><p>
Negotiate reimbursement requests.</p></li><li><p>
Communicate adverse event issues with the appropriate our company's field representatives.</p></li><li><p>
Handle technical inquiries on the product line &ndash; 30%</p></li><li><p>
Review and approve cases in PV Works &ndash; 15%</p></li><li><p>
Provide training on products and pharmacovigilance procedures/compliance to Pharmacovigilance team.</p></li><li><p>
PV procedure training may also be requested for marketing and sales forces &ndash; 0-5%</p></li><li><p>
Assist in departmental projects/committees as needed &ndash; 0-5%</p></li><li><p>
Assist with field-based activities on an as-needed basis. &ndash; 0-5%</p></li><li><p>
May be requested to assist the Technical Services group cover meetings, clinic visits or to follow-up on pharmacovigilance issues as the need arises.</p></li></ul><p></p><p><b><br>
BACKGROUND REQUIREMENTS</b></p><ul><li><p>
Doctor of Veterinary Medicine (DVM/VMD) degree</p></li><li><p>
3 years of private practice experience in a small or mixed-animal practice. Experience working in the pharmaceutical industry as a Pharmacovigilance Veterinarian preferred.</p></li><li><p>
Excellent interpersonal and phone skills, with a strong commitment to Customer Service.</p></li><li><p>
Computer literacy and strong comfort level working with databases. Preferred experience with Microsoft Outlook, and Microsoft Office.</p></li><li><p>
Compliance focused mindset, strong organizational skills and attention to detail are essential.</p></li><li><p>
Must hold either a current license to practice veterinary medicine or has held one in the past but relinquished it due to lack of need in current position.</p></li><li><p>
The position is remotely based. The candidate will need to have a designated quiet private home office workspace and must be able to focus full attention to work during their scheduled shifts.</p></li><li><p>
The candidate must have or be willing to obtain hard wired reliable internet services and meet the minimum internet speed requirements of 30 Mbps download and 10 Mbps upload.</p></li><li><p>
Special interest in Vaccinology/Immunology, Endocrinology, Dermatology, or Oncology preferred</p></li></ul><p></p><p><b>
Required Skills:
</b></p>Adaptability, Adverse Event Report, Animal Health Care, Compliance Monitoring, Drug Safety Surveillance, Pharmacovigilance, Risk Management, Veterinary Consulting, Veterinary Medicine, Veterinary Pathology<p></p><p><b>
Preferred Skills:</b></p><p></p><p><b><br>
US and Puerto Rico Residents Only:</b></p><p></p><p>
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.</p><p>
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:</p><p></p><p>
EEOC Know Your Rights</p><p>
EEOC GINA Supplement
</p><p></p><p>We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another&rsquo;s thinking and approach problems collectively.</p><p></p><p>
Learn more about your rights, including under California, Colorado and other US State Acts</p><p></p><p>
The salary range for this role is</p>
$117,000.00 - $184,200.00<p></p><p>
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee&rsquo;s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.</p><p></p><p>
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.</p><p></p><p>
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.</p><p></p><p>
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.</p><p></p><p><b>
San Francisco Residents Only:</b> We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance</p><p></p><p><b>
Los Angeles Residents Only:</b> We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles&rsquo; Fair Chance Initiative for Hiring Ordinance</p><p></p><p><b>
Search Firm Representatives Please Read Carefully</b><br>
Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.</p><p></p><p><b>
Employee Status:
</b></p>Regular<p></p><p><b>
Relocation:</b></p>
No relocation<p></p><p><b>
VISA Sponsorship:</b></p>
No<p></p><p><b>
Travel Requirements:</b></p>
No Travel Required<p></p><p><b>
Flexible Work Arrangements:</b></p>
Remote<p></p><p><b>
Shift:</b></p>
1st - Day<p></p><p><b>
Valid Driving License:</b></p>
No<p></p><p><b>
Hazardous Material(s):</b></p>
N/A<p></p><p><b>
Job Posting End Date:</b></p>
05/19/2026<ul><li><b>A job posting is effective until 11:59:59PM on the day </b><b>BEFORE</b><b> the listed job posting end date. Please ensure you apply to a job posting no later than the day </b><b>BEFORE</b><b> the job posting end date.<br>
</b></li></ul><br>
<p><b>Requisition ID:</b>R393333</p></div>

Companion Animal Pharmacovigilance Veterinarian

Capgemini

<div><div><div><div><p>At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities, collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow. Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose.
</p><div><div><div><h2 class="jobSectionHeader"><b>Your Role</b></h2>
</div><div><div>As a Senior Consultant, you will act as a pharmacovigilance and drug safety expert for pharmaceutical and biotech clients, supporting safety across the product lifecycle - from clinical development to post-market. You&rsquo;ll collaborate with Principals and Managers on projects such as safety system implementations, process optimization, aggregate safety reporting, signal detection, risk management, and regulatory compliance. This role offers opportunities to work with varied product types (small molecules, biologics, vaccines, advanced therapies) and integrate AI/ML into pharmacovigilance practices.</div>
<div></div><div>Key Focus Areas</div>
<ul><li><div>Pharmacovigilance and drug safety consulting for Life Sciences clients</div>
</li><li><div>Safety system optimization (e.g., Argus, LifeSphere, Vault Safety)</div>
</li><li><div>Aggregate safety reporting (PSURs, PBRERs, DSURs)</div>
</li><li><div>Signal detection, risk management, and ICSR processing</div>
</li><li><div>Safety compliance (GVP, FDA, ICH E2 guidelines)</div>
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>Qualifications &amp; Experience</b></h2>
</div><div><div>Skills and Experience</div>
<div>Required:</div>
<ul><li><div>6&ndash;10 years hands-on pharmacovigilance experience in safety operations, ICSR processing, aggregate reporting, signal detection, or safety system administration.</div>
</li><li><div>Expert knowledge of PV regulations: FDA (21 CFR 312.32, 314.80, FAERS), EMA GVP (Modules VI, VII, IX), and ICH E2 (E2A-E2F).</div>
</li><li><div>Direct experience with ICSR processing: intake, triage, medical review, causality assessment (WHO-UMC, Naranjo), MedDRA coding, narrative writing, and regulatory submissions.</div>
</li><li><div>Practical use of safety databases (e.g., Argus, LifeSphere, Vault Safety, IQVIA Vigilance, AB Cube).</div>
</li><li><div>Experience with aggregate safety reports: PSURs/PBRERs, DSURs, Annual Safety Reports, and benefit-risk analysis.</div>
</li><li><div>Knowledge of signal detection methods (statistical/data mining, literature review, clinical judgment).</div>
</li><li><div>Bachelor&rsquo;s in life sciences, pharmacy, nursing, or related field; advanced degree (PharmD, MD, MS, MPH) preferred.</div>
</li><li><div>Eligible to work in the U.S. without visa sponsorship.</div>
</li><li><div>Proficient with MedDRA (coding, conventions, versioning) and knowledge of WHO-DD.</div>
</li><li><div>Understanding of E2B(R3) standards for electronic ICSR transmission (FAERS, EudraVigilance).</div>
</li><li><div>Strong analytical and medical writing skills (narratives, signal evaluation, safety reports).</div>
</li><li><div>Proven ability to collaborate with clinical, regulatory, medical, QA, and IT teams.</div>
</li><li><div>Consulting skills: capability assessment, gap identification, solution recommendation.</div>
</li></ul><ul><li>Mastery of Microsoft Office (Excel, PowerPoint, Word).</li>
</ul><div>Preferred:</div>
<ul><li><div>Clinical background (MD, PharmD, RN, PA).</div>
</li><li><div>PV certification (DSS, CPP, or equivalent).</div>
</li><li><div>Experience in pharma/biotech PV operations and/or at CROs with PV services.</div>
</li><li><div>Consulting experience (Big 4 or life sciences consultancies) in PV projects.</div>
</li><li><div>Involvement in regulatory inspections (FDA/EMA GVP), and audit readiness.</div>
</li><li><div>Experience with REMS programs (design, implementation, assessment).</div>
</li><li><div>Knowledge of specialty product safety (biologics, vaccines, oncology, gene/cell therapies, ATMPs).</div>
</li><li><div>Familiarity with real-world evidence for safety (claims databases, EHR, registries, social media).</div>
</li><li><div>Understanding of AI/ML in PV (NLP, signal detection, predictive analytics, workflow automation).</div>
</li><li><div>Experience with data visualization tools (Tableau, Spotfire, Power BI).</div>
</li><li><div>Exposure to international PV regulations (PMDA, Health Canada, ANVISA, etc.).</div>
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>Short Description</b></h2>
</div><div><p>At Capgemini Invent, we empower our people to explore, innovate, and progress. As a global community of entrepreneurial thinkers, you&rsquo;ll be encouraged to step up, try new things, and make a mark. As part of Capgemini Invent, you&rsquo;ll have the flexibility to work your own way and find your balance. We give you the ownership and support you need to grow your skills and shape your future path.</p>
<div><div><h3 class="jobSectionHeader"><b>Hybrid working</b></h3>
<p>We believe that flexibility is the key to a healthy work-life balance. That&rsquo;s why our employees work with their managers to determine an arrangement that works best for their role and personal circumstances.</p>
</div><div><h3 class="jobSectionHeader"><b>Flex abroad</b></h3>
<p>Capgemini&rsquo;s Flex Abroad program gives employees the opportunity to work abroad for up to 45 days in a 12-month period. This allows you to temporarily change your working environment while staying connected to your team and career goals.</p>
</div></div></div></div></div><p>The base compensation range for this role in the posted location is: $112,240 - $200,560.</p>
<p>Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.</p>
<p>The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.</p>
<p>These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.</p>
<p>It is not typical for candidates to be hired at or near the top of the posted compensation range.</p>
<p>In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.</p><br>
<p></p><p><b>Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees.</b> In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:</p>
<ul><li>Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave</li>
</ul><ul><li>Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)</li>
<li>Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)</li>
<li>Life and disability insurance</li>
<li>Employee assistance programs</li>
<li>Other benefits as provided by local policy and eligibility</li>
</ul><p><b>Important Notice:</b> Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini&rsquo;s discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.</p><br>
<p></p><p><b>Disclaimers</b></p>
<p>Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion and respect. We value the rich cultural heritage and contributions of Indigenous Peoples and actively work to create a welcoming and respectful environment. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.</p>
<p>This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodation does not pose an undue hardship. Capgemini is committed to providing reasonable accommodation during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.</p>
<p>Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.</p>
<p>Click the following link for more information on your rights as an Applicant in the United States. http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law</p><br>
<p></p><p>Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.</p></div></div></div></div><p></p>

Capgemini Invent - LS Pharmacovigilance, Sr Consultant 1

<div>
 Our ever-growing
 <strong>
  Lifecycle Safety Medical
 </strong>
 team is expanding. The role participates in all aspects of the Medical Safety activities as per scope of work. This includes, but is not limited to providing and maintaining of PV and risk management expertise to internal and external stakeholders, maintaining knowledge relevant to allocated product portfolios, conducting medical evaluation of post-marketing adverse drug reactions, review and contribution to signal management and benefit-risk evaluation of drugs in clinical trial and post marketing set up, preparation, and/or contribution to responses to questions from health authorities, reviewing and contributing to periodic aggregate reports, contributing to safety review of study protocols, investigators brochure and other reference safety information, and serving as an internal consultant for any medical support for pharmacovigilance operations.
 <br/>
 <br/>
 Associate Medical Safety Director
 <br/>
 <br/>
 <strong>
  Role Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product&rsquo;s safety profile
  </li>
  <li>
   Leads signal detection and analysis, including, signal detection strategy, frequency, and timing, reviews the Signal Detection Reports and other sources of data as applicable, raises potential signals for team discussion, contributes to safety analysis reports presentations of signal evaluation data as appropriate
  </li>
  <li>
   Providing medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
  </li>
  <li>
   Providing medical review and contribution to Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
  </li>
  <li>
   Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up
  </li>
  <li>
   Providing safety oversight and contribution for label development, review, and updates
  </li>
  <li>
   Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
  </li>
  <li>
   Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary and serve as an internal consultant to pharmacovigilance case processing teams
  </li>
  <li>
   Representing safety and clinical data review findings during internal and external stakeholder meetings
  </li>
  <li>
   Providing medical safety support, contribution, and attendance at Safety Governance and other Meetings as needed
   <br/>
   <br/>
  </li>
 </ul>
 Do you have the skills, experience and qualification required for the role:
 <br/>
 <br/>
 <ul>
  <li>
   A medical degree from an accredited and internationally recognized medical school
  </li>
  <li>
   Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experience
  </li>
  <li>
   Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice and clinical trials and pharmaceutical research process
  </li>
  <li>
   Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature
  </li>
  <li>
   Experience in Signal detection, Aggregate reports and Risk management.
  </li>
  <li>
   Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writing
  </li>
  <li>
   Ability to establish and meet priorities, deadlines, and objectives
  </li>
  <li>
   Demonstrated skills in contributing to multiple assignments required, capacity to work under pressure as well as initiative and flexibility and ability to adapt to changing business needs
  </li>
  <li>
   Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed
   <br/>
   <br/>
  </li>
 </ul>
 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
 <br/>
 <br/>
 IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
</div>


Associate Medical Safety Director- Sponsor Dedicated

Sanofi

<div><h3 class="jobSectionHeader"><b><i>About Sanofi:</i></b></h3><h3 class="jobSectionHeader"><b>
We&rsquo;re an R&amp;D-driven, AI-powered biopharma company committed to improving people&rsquo;s lives and delivering compelling growth. Our deep understanding of the immune system &ndash; and innovative pipeline &ndash; enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people&rsquo;s lives.</b></h3><p></p><h3 class="jobSectionHeader"><b><i>
About the job</i></b></h3><ul><li><h3 class="jobSectionHeader"><b>
Define, implement and maintain the Partner Market PV business model under the direction of the Multi-Country Safety Head ((M)-CSH). ensure an effective oversight and management of the Partner Market Service Providers (PMSP) across the MCO/region including regular meetings with the PMSPs, monitoring compliance with the PV Agreements (PVAs) and maintenance of the PVA.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Ensure the implementation of PV in assigned territories, acting as the interface between PSPV, the (M)CSH and the PMSPs.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Transversal coordination: ensures PV training, processes and tools are in place with the PMSPs, ensures that they are compliant with PV standards and are harmonized across countries. The Partner Market PV Manager shall identify areas of risk and escalate and work with stakeholders to resolve. Promote and deploy initiatives aimed at harmonizing and promoting best practices across PMSPs within assigned territory (if applicable). In addition, when appropriate, he/she may need to work collaboratively with the Global PSPV SMEs in developing process-related solutions oriented at the PMSPs as well as interacting closely with other PSPV functions to contribute to the appropriate management of the Sanofi PV system.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Is the contact point between PMSPs and the Global PV teams, and performs other activities which require a coordination role as new process implementation, communication to partners, implementation of additional Risk Minimization Measures and its tracking, contribution to the PSMF, supports Inspection and Audit activities etc.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Work collaboratively with other Sanofi functions contributing to the success of the PMSPs collaboration.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Serves as back-up for Partner Market PV Managers in other territories/Regions as required</b></h3></li></ul><p></p><h3 class="jobSectionHeader"><b>
Key Accountabilities:</b></h3><ul><li><h3 class="jobSectionHeader"><b>
Manage great customer experience: Acts as the contact point/interface between PSPV/internal and external stakeholders (i.e Partner Market Service Providers)</b></h3></li><li><h3 class="jobSectionHeader"><b>
Oversees the Partner Market Service Providers ensuring the maintenance and compliance with the PVAs. Ensures all Partner Market Service Providers meet KPIs set by PSPV, and oversee compliance of partners with applicable regulations.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Routine management and support of the PV aspects of the Partner Market Services Providers, including support for audit and inspection.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Participates in the Due diligence activities to select the service provider for PV activities when applicable.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Follows up overall project implementation plan for new Partner Markets implementation, which involves the transition of PV activities to partners in countries in scope and ensure no noncompliance.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Keeps the Multi-Country Safety Head informed on the status of the allocated Partnerships escalating issues as needed.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Ensures the Multi-Country Safety Head has the comprehensive oversight and management of all the partnerships for the delegated PV activities including monitoring and enforcement of Partners compliance with the PV Agreements.</b></h3></li><li><h3 class="jobSectionHeader"><b>
In collaboration with other Partner Market PV Managers: Coordinates the implementation of the PV activities consistently across PMSPs in the assigned territories when applicable. Ensures back-up functions are in place across MCO/Regions as applicable.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Is in charge of the monitoring of the budget of PMSP activities, in collaboration with the (M)-CSH.</b></h3></li></ul><h3 class="jobSectionHeader"><b><i>
About you
</i></b></h3><h3 class="jobSectionHeader"><b>Education:</b></h3><ul><li><h3 class="jobSectionHeader"><b>
MD, Pharmacist, PhD or master&rsquo;s degree in Human Health Sciences</b></h3></li></ul><h3 class="jobSectionHeader"><b>
Experience &amp; knowledge:</b></h3><ul><li><h3 class="jobSectionHeader"><b>
Minimum 4 years&rsquo; experience in managing Pharmacovigilance activities in close collaboration with key departments (Medical Affairs, Regulatory, Clinical, Quality Assurance, etc.) or equivalent experience.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Experience working in multinational environment, across diverse cultures</b></h3></li><li><h3 class="jobSectionHeader"><b>
Experience with PV agreements and or PV partnerships and partner/vendor relations</b></h3></li><li><h3 class="jobSectionHeader"><b>
Experience in transversal projects</b></h3></li><li><h3 class="jobSectionHeader"><b>
Knowledge of other languages, Fluency in French is advantageous.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Country PV experience is an asset.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Experience with Clinical Safety related activities can be a plus</b></h3></li><li><h3 class="jobSectionHeader"><b>
Knowledge of other languages. Fluency in French is advantageous</b></h3></li><li><h3 class="jobSectionHeader"><b>
Project management experience.</b></h3></li></ul><h3 class="jobSectionHeader"><b>
Competencies:</b></h3><ul><li><h3 class="jobSectionHeader"><b>
Excellent organizational and planning capabilities</b></h3></li><li><h3 class="jobSectionHeader"><b>
Strong negotiation skills</b></h3></li><li><h3 class="jobSectionHeader"><b>
Strong interpersonal skills</b></h3></li><li><h3 class="jobSectionHeader"><b>
Strong leadership competencies</b></h3></li><li><h3 class="jobSectionHeader"><b>
Team player</b></h3></li><li><h3 class="jobSectionHeader"><b>
Fluency in English (both oral and written, including technical terminology) and communication skills (oral/written)</b></h3></li><li><h3 class="jobSectionHeader"><b>
Inter-cultural skills/ability to work across cultures.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Demonstrate problem solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in QDs, Operational Manuals and Guidance documents. Capacity to work under pressure</b></h3></li></ul><p></p><h3 class="jobSectionHeader"><b><i>
Take The Lead Values:</i></b></h3><ul><li><h3 class="jobSectionHeader"><b><i>
Aim Higher</i></b><b> - Focus on what matters, set high standards and move with urgency, learning from setbacks as we go to achieve higher performance.</b></h3></li><li><h3 class="jobSectionHeader"><b>
 </b><b><i>Act for patients</i></b><b> - Never compromise on integrity, eliminate barriers, and partner with others to go faster and further for patients.</b></h3></li><li><h3 class="jobSectionHeader"><b>
 </b><b><i>Be Bold</i></b><b> - Take thoughtful risks, seize opportunities and think beyond what&rsquo;s possible to accelerate our science and drive compelling growth.</b></h3></li><li><h3 class="jobSectionHeader"><b><i>
Lead Together</i></b><b> - Build trust and collaborate openly on our shared goals, celebrate collective wins and foster a sense of belonging.</b></h3></li></ul><h3 class="jobSectionHeader"><b><i>
Why choose us?</i></b></h3><ul><li><h3 class="jobSectionHeader"><b>
Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Help improve the lives of millions of people globally by making drug development quicker and more effective.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Accelerate your professional development with structured career paths designed for both scientific and leadership advancement. Grow in ways you never imagined through bold moves that stretch your potential, cross moves into other business areas, and short-term gigs that build your scientific expertise.
</b></h3></li><li><h3 class="jobSectionHeader"><b>Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Achieve genuine work-life balance in a supportive R&amp;D environment.</b></h3></li><li><h3 class="jobSectionHeader"><b>
Enjoy outstanding benefits, including flexible working options, comprehensive healthcare, and well-being programs designed to help you thrive.</b></h3></li></ul>
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Partner Market PV Manager – Sub Saharan Africa

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Capgemini Invent - LS Pharmacovigilance, Sr Consultant 1

Associate Medical Safety Director- Sponsor Dedicated

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