pharmacovigilance specialist

Acino

<div><p>Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.</p><p></p><p><br>
This position is based in <b>Cairo, Egypt</b> and will report directly to the <b>Pharmacovigilance Head META.</b> The role will be responsible for monitoring, assessing, and reporting the safety of pharmaceutical products, ensuring compliance with global regulatory standards.</p><br>
<p></p>
<p><b>
Your Responsibilities will be:</b></p><p></p><p><b><br>
Safety Data Exchange Agreements (SDEAs)</b></p>
<ul>
<li>Draft, negotiate, and maintain SDEAs with business partners in META region in compliance with corporate and regulatory requirements.</li>
<li>Ensure timely execution and periodic review of SDEAs, including reconciliation of safety responsibilities and timelines in coordination with GPV.</li>
<li>Track SDEA obligations and ensure alignment with internal SOPs and global PV standards.</li>
<li>Coordinate with legal, regulatory, and compliance teams to ensure contract integrity and audit readiness.</li></ul><br>
<p></p>
<p><b>
Business Partner (BP) Communication</b></p>
<ul>
<li>Act as the primary PV liaison for regional business partners, distributors, and license holders.</li>
<li>Ensure timely exchange of safety data and compliance with agreed pharmacovigilance obligations.</li>
<li>Provide PV Onboarding/Refreshing training to BPs in alignment with global procedures.</li>
<li>Monitor BP compliance metrics and escalate deviations or risks as needed.</li></ul><br>
<p></p>
<p><b>
Management of Internal CAPAs and deviations</b></p>
<ul>
<li>Managing internal CAPAs and deviations in TrackWise, documenting quality events, assigning corrective actions, tracking progress, and ensuring compliance through automated workflows and audit-ready records.</li></ul><br>
<p></p>
<p><b>
Global PSMF Maintenance
</b></p><ul><li>Ensure Global PSMF remains accurate, up-to-date, and compliant with regulatory requirements across all applicable regions.</li>
<li>Maintain the regional annexes of the Global Pharmacovigilance System Master File (PSMF)</li></ul><br>
<p></p>
<p><b>
Assigned tasks from GPV responsibilities</b></p>
<ul>
<li>Conduct regular screening of scientific and medical literature to identify potential adverse events and ensure compliance with global pharmacovigilance requirements</li>
<li>Prepare and review periodic safety update reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and other aggregate safety reports to summarize the benefit-risk profile of medicinal products.</li>
<li>Develop and maintain risk management plans (RMPs) to proactively identify, assess, and mitigate safety risks associated with pharmaceutical products.</li>
<li>Perform signal detection and evaluation activities to identify new safety concerns and trends from various data sources</li>
<li>Performs other tasks under direction of Director PV Operations if requested.</li></ul><br>
<p></p>
<p><b>
SOPs management</b></p>
<ul>
<li>Oversee the development, implementation, and periodic review of pharmacovigilance Standard Operating Procedures (SOPs) to ensure regulatory compliance, operational consistency, and alignment with global quality standards.</li></ul><br>
<p></p>
<p><b>
Your Profile:</b></p><br>
<p></p><ul>
<li>
A university degree in Pharmacy, Medicine, Life Sciences, or related field.</li>
<li>Minimum 5-8 years&rsquo; experience in pharmacovigilance, with direct experience managing SDEAs and partner communications.</li>
<li>Excellent user of MS Office applications (Word, Excel, PowerPoint, Outlook).</li>
<li>Ability to learn about new technologies, strategies and policies, with high level of compliance with policies. Experience with electronic systems and databases.</li>
<li>Fluent in English, both in oral and in writing.</li>
<li>Full understanding of legal/compliance environment and requirements.</li></ul><br>
<p></p>
<p>
This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!</p></div>

Senior Pharmacovigilance (PV) Specialist META

<div><b>Site Name:</b> UAE - Dubai<br>
<b>Posted Date:</b> Nov 18 2025<p><b><br>
Position Summary</b></p><p>
We are inviting <b>UAE Nationals</b> to join our Pharmacovigilance team in the UAE as a <b>Pharmacovigilance Associate</b>. In this role you will collect, assess and report safety information in accordance with local and global regulatory requirements. You will collaborate with safety scientists, medical experts and cross-functional partners to support timely case management, signal detection and regulatory reporting. We are seeking team members who value accuracy, clear communication, ethical conduct and continuous learning.</p><p></p><p><b>
Key Responsibilities</b></p><ul><li>
Receive, document and triage safety reports from healthcare professionals, patients and internal colleagues, ensuring confidentiality of personal data at all times.</li><li>
Perform initial case assessment and follow-up to obtain complete and accurate information for case evaluation.</li><li>
Accurately enter case data into pharmacovigilance databases and maintain data quality and completeness.</li><li>
Prepare and submit safety reports to health authorities and internal stakeholders according to local and company reporting timelines and procedures.</li><li>
Support routine safety reporting, expedited reporting and signal detection activities in line with company and regulatory requirements.</li><li>
Collaborate with cross&#8209;functional teams (medical affairs, clinical, regulatory, legal, commercial) to resolve safety queries and support compliance activities.</li><li>
Adhere to GSK policies on patient privacy, data protection, pharmacovigilance SOPs and ethics.</li></ul><p></p><p><b>
Basic Qualifications</b></p><ul><li>
UAE National with family book.</li><li>
Bachelor&rsquo;s degree in pharmacy, life sciences, nursing, medicine or a related discipline.</li><li>
Previous exposure to pharmacovigilance, drug safety, or a clinical/healthcare environment.</li><li>
High attention to detail, accuracy in data entry and good organisational skills.</li><li>
Strong written and verbal communication skills in English; Arabic language skills are an advantage.</li><li>
Proficiency in Microsoft Office applications.</li></ul><p><b>
Preferred Qualifications</b></p><ul><li>
Experience with safety databases, case management systems or pharmacovigilance tools.</li><li>
Knowledge of UAE pharmacovigilance regulations and local reporting timelines.</li><li>
Formal pharmacovigilance/drug safety training or certification.</li><li>
Able to manage multiple priorities and meet regulatory deadlines.</li><li>
Experience engaging with health authorities, healthcare professionals or working in multinational teams.</li></ul><p></p><p><b>
Additional Information:</b><br>
This role is based on-site in Dubai, United Arab Emirates.</p><p></p><p><b>
Application Process:</b><br>
If you&rsquo;re ready to grow your skills, make a positive impact, and contribute to GSK&rsquo;s mission, apply today!</p><p></p><p>
GSK is an equal opportunity employer and values diversity, equity, and inclusion. We welcome applications from UAE Nationals who are passionate about improving lives and ensuring compliance with local regulations.</p><p></p><p><b>
Why GSK?</b><br>
<b>Uniting science, technology and talent to get ahead of disease together.</b></p><p></p><p>
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases &ndash; to impact health at scale.</p><p></p><p>
People and patients around the world count on the medicines and vaccines we make, so we&rsquo;re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.</p><p></p><p><b>
Contact information:</b><br>
You may apply for this position online by selecting the <b>Apply now</b> button.</p><p></p><p><b>
Important notice to Employment businesses/ Agencies</b></p><p>
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.</p></div>

Pharmacovigilance Associate - UAE National

Mirador Therapeutics

<div><div><p>Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company's Mirador360 TM precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA.</p></div><p><b>
Summary</b></p>
<p>
The Director, Pharmacovigilance (PV) will lead and oversee safety reporting activities across clinical programs, with a primary focus on managing and coordinating pharmacovigilance deliverables with Contract Research Organizations (CROs). This role ensures compliance with global regulatory requirements, company SOPs, and high-quality execution of safety reporting obligations. This position will act as the key liaison between internal stakeholders and CRO partners to drive operational excellence and regulatory compliance in pharmacovigilance activities.</p>
<p><b>
Responsibilities</b></p>
<ul>
<li>Oversee all safety reporting activities managed by CROs, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs).</li>
<li>Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations.</li>
<li>Develop, negotiate, and manage PV sections of contracts, safety management plans, and operational agreements with CROs.</li>
<li>Monitor CRO performance through KPIs, audits, and oversight activities, ensuring timely and accurate reporting to regulatory authorities, ethics committees, and investigators.</li>
<li>Lead safety reporting governance, including escalation of significant safety issues, compliance deviations, and regulatory queries.</li>
<li>Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, Quality, Legal) to ensure alignment on PV strategy and compliance.</li>
<li>Provide oversight for case processing, medical review, and data reconciliation activities performed by CROs.</li>
<li>Ensure compliance with global regulations (FDA, EMA, MHRA, ICH, GVP, etc.) and maintain inspection readiness.</li>
<li>Support development and maintenance of internal PV policies, SOPs, and training programs.</li>
<li>Participate in safety signal detection activities and safety governance committees, as needed.</li>
<li>Oversee maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events.</li>
<li>Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations.</li>
</ul>
<p><b>Experience and Qualifications</b></p>
<ul>
<li>Bachelor's degree; advanced degree a plus.</li>
<li>10 or more years of pharmacovigilance experience, including at least 5 years in a leadership or oversight role.</li>
<li>Strong experience managing CRO/vendor relationships, particularly in clinical trial safety reporting.</li>
<li>Deep knowledge of global pharmacovigilance regulations, GVP, ICH guidelines, and relevant reporting requirements.</li>
<li>Experience with oversight of drug safety databases (e.g., Oracle Argus).</li>
<li>Proven track record of ensuring compliance in a global PV environment.</li>
</ul>
<p><b>Skills and Abilities</b></p>
<ul>
<li>Strong ability to build and maintain excellent interpersonal relationships, both within and outside the company, at all levels, and work within, lead and motivate a cross-functional matrixed team.</li>
<li>Self-motivated; engaged, hands-on, entrepreneurial style with a sense of urgency, a bias toward action, and flexibly contribute simultaneously in multiple facets of drug development; willingness to learn new therapeutic areas.</li>
<li>Analytical and problem-solving skills; risk identification and management; creative and innovative thinking.</li>
<li>The requisite scientific acumen and communication skills to influence and collaborate with key scientific, regulatory, and business leaders.</li>
<li>Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity.</li>
<li>Excellent communication, negotiation, and leadership skills.</li>
</ul>
<p>The expected base pay range for this position is $195,000 &ndash; $220,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.</p><br>
<p></p>
<p>
#LI-onsite</p><div><p>
Working at Mirador Therapeutics | Great Place To Work&reg;</p>
<p>
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.</p>
<p>
Read our Job Applicant Privacy Policy</p></div></div>

Director, Pharmacovigilance - San Diego, CA

ProPharma

<div>
 For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality &amp; compliance, pharmacovigilance, medical information, and R&amp;D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners&rsquo; most high-profile drug and device programs.
 <br/>
 <br/>
 <strong>
  Job Summary
  <br/>
  <br/>
 </strong>
 The Pharmacovigilance (PV) Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed. The PV Safety Scientist is expected to be professional and diligent and liaise with the director and management group members within the team on any issues, as well as coordinate the work with the senior PV Scientists. The PV Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company.
 <br/>
 <br/>
 <strong>
  Essential Functions
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities.
  </li>
  <li>
   Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
  </li>
  <li>
   Authoring of Signal Management Reports.
  </li>
  <li>
   Performing literature search and validity check for the aggregate reports.
  </li>
  <li>
   Reconciliation of relevant process trackers.
  </li>
  <li>
   Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).
  </li>
  <li>
   Generation of Line Listings (LL) from safety database
  </li>
  <li>
  </li>
  <li>
   Providing reliable support for high priority Ad-hoc activities.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Necessary Skills And Abilities.
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Analytical and problem-solving skills.
  </li>
  <li>
   Sound organizational skills
  </li>
  <li>
   Able to work within a team in an open and professional manner
  </li>
  <li>
   Excellent attention to detail and focus on quality
  </li>
  <li>
   Understanding of ICH-GCP, FDA, EMA and other relevant Global regulations related to PV
  </li>
  <li>
   Demonstrable ability to analyze and quantify large volumes of data in a concise and scientific manner, in keeping with regulatory deadlines.
  </li>
  <li>
   Awareness of global culture and willingness to work in a matrix environment
  </li>
  <li>
   Knowledge in other pharmacovigilance processes, ability to author/update SOPs or WIs, to identify and author deviations/CAPAs."
  </li>
  <li>
   Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines.
  </li>
  <li>
   Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
  </li>
  <li>
   Computer proficiency, IT skills, expertise and an ability to work with web based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
   <br/>
   <br/>
  </li>
 </ul>
 Educational requirements
 <br/>
 <br/>
 <ul>
  <li>
   Bachelor/master&rsquo;s degree in pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Experience Requirements
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   2+ years&rsquo; experience in Pharmacovigilance with a focus on medical writing and/or literature search and/or signal detection
  </li>
  <li>
   Experiences in contributing to the compilation of metrics and participating in discussions about quality internally and with Clients
  </li>
  <li>
   Experience in literature screening activities and/or experiences in authoring and reviewing aggregate reports
   <br/>
   <br/>
  </li>
 </ul>
 We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
 <br/>
 <br/>
 ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
</div>


Pharmacovigilance Safety Scientist

Syneos Health

<div>
 <strong>
  Description
  <br/>
  <br/>
 </strong>
 Safety &amp; PV Specialist II (Literature Review)
 <br/>
 <br/>
 Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
 <br/>
 <br/>
 Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
 <br/>
 <br/>
 Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
 <br/>
 <br/>
 Discover what our 29,000 employees, across 110 countries already know:
 <br/>
 <br/>
 <strong>
  WORK HERE MATTERS EVERYWHERE
  <br/>
  <br/>
 </strong>
 Why Syneos Health
 <br/>
 <br/>
 <ul>
  <li>
   We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  </li>
  <li>
   We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  </li>
  <li>
   We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Job Responsibilities
  <br/>
  <br/>
 </strong>
 <strong>
  JOB RESPONSIBILITIES
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety-relevant information.
  </li>
  <li>
   Skilled in extracting and summarizing key safety information from identified literature sources
  </li>
  <li>
   Thorough understanding of creating and validating search strategies for pharmacovigilance purpose.
  </li>
  <li>
   In depth knowledge of major literature databases such as Embase, PubMed etc.
  </li>
  <li>
   Experience in conducting local literature searches and reviews.
  </li>
  <li>
   Understanding of regulatory requirements with respect to global and local literature.
  </li>
  <li>
   Enters information into PVG quality and tracking systems for receipt and tracking ICSR.
  </li>
  <li>
   May assist in the preparation of the Safety Management Plan
  </li>
  <li>
   Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
  </li>
  <li>
   Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
  </li>
  <li>
   Enters data into safety database.
  </li>
  <li>
   Codes events, medical history, concomitant medications and tests.
  </li>
  <li>
   Compiles complete narrative summaries.
  </li>
  <li>
   Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
  </li>
  <li>
   Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
  </li>
  <li>
   Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases.
  </li>
  <li>
   Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
  </li>
  <li>
   Participate in audits/inspections as required
  </li>
  <li>
   Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
  </li>
  <li>
   Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.
   <br/>
   <br/>
  </li>
 </ul>
 Good communication and interpersonal skills, both written and spoken
 <br/>
 <br/>
 Bachelor&rsquo;s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
 <br/>
 <br/>
 <strong>
  What We&rsquo;re Looking For
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s Degree, Postgraduate in health profession with relevant experience, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
  </li>
  <li>
   At least 3+ years of experience in Pharmacovigilance, Literature case reviewing (Global+Local), Identifying NICR (Signal &amp; AR) report from Literature.
  </li>
  <li>
   Mandatory to have GVP Module 6 knowledge
  </li>
  <li>
   Safety Database systems and knowledge of medical terminology required
  </li>
  <li>
   Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
  </li>
  <li>
   Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.
  </li>
  <li>
   Ability to work independently and in a team environment
  </li>
  <li>
   Good communication and interpersonal skills, both written and spoken
  </li>
  <li>
   Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
  </li>
  <li>
   Detail oriented with a high degree of accuracy and ability to meet deadlines
  </li>
  <li>
   Minimal travel may be required (up to 5%)
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Get to know Syneos Health
  <br/>
  <br/>
 </strong>
 Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
 <br/>
 <br/>
 No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
 <br/>
 <br/>
 http://www.syneoshealth.com
 <br/>
 <br/>
 <strong>
  Additional Information
  <br/>
  <br/>
 </strong>
 Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
 <br/>
 <br/>
 <strong>
  Summary
  <br/>
  <br/>
 </strong>
 Performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR), adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs.
</div>


Safety & PV Specialist II (Literature Review)

Pfizer

<div><div>In this pharmacovigilance role, you will carry out processing activities of Individual Case Safety Reports (both clinical trials and post-marketing sources) in the ARGUS Safety database.</div><div>
Processing activities include assessing case validity, undertaking duplicate checks, creating cases in the database, prioritizing cases as per company guidance, updating cases with information provided in XML source documents, identifying adverse events, confirming their seriousness, coding products, undertaking causality and listedness assessments, drafting narratives, determining appropriate case follow-up, reviewing processed cases to verify technical judgment, accuracy, and compliance with company requirements, etc.</div><div></div><div>
Here Is What You Need (Minimum Requirements):</div><div></div><div>
Education = B. Pharm, M. Pharm, or Pharm. D only.</div><div>
Experience = FRESHERS ONLY!</div><div>
Keen attention to detail.</div><div>
Solid analytical skills.</div><div>
Good written and oral communication skills.</div><div>
Collaborative skills.</div><div>
Continuous Learning.</div><div></div><div>
Bonus Points If You Have (Preferred Requirements):</div><div></div><div>
Course completion and/or certification in Pharmacovigilance or good knowledge of medical terminology and global regulatory requirements for drug safety.</div><div>
Publications in peer reviewed journals.</div><div><br>
<br>
Work Location Assignment: Hybrid.</div><br>
<br>
Work Location Assignment: Hybrid<div></div><div><br>
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.</div><div></div>
Medical</div><div></div>

Associate Safety Data Management Specialist

Search 4965+ Pharmacovigilance specialist jobs near you this November. New roles added regularly across leading industries. Apply today.

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