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associate director pharmacovigilance quality assurance auditor

Organon Pharmaceuticals

<p></p><div><p><b>The position</b></p><p>
The Associate Director, Pharmacovigilance (PV) Quality Assurance Auditor, is responsible for ensuring quality and compliance with local and international regulatory requirements by conducting audits of Organon Processes, Affiliates, Vendors, Business Partners, and Investigator sites. The Associate Director is responsible for accepting audit assignments, performing audit pre-work, conducting audits and ensuring post audit activities are completed within defined timeframes. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and prevention of compliance risks.</p><p></p><p><b>
Responsibilities:</b></p><ul><li><p>
Schedule and conduct assigned PV audits in accordance with the global audit plan ensuring compliance with local and international guidelines and regulations.</p></li><li><p>
Prepare audit reports and manage follow-up activities within established timelines.</p></li><li><p>
Maintain broad-based expertise in Organon Policies, Procedures and Guidelines, local and global regulatory requirements, etc., pertinent to GVP. Maintain awareness of evolving industry and regulatory trends/regulations.</p></li><li><p>
Obtain and maintain cutting-edge knowledge, and application, for various Quality auditing topics.</p></li><li><p>
Generate and present comprehensive presentations/summary of audit issues for effective communication to all levels, as needed.</p></li><li><p>
Leads initiatives / drive results in various projects, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet company and regulatory expectations.</p></li><li><p>
Supports the implementation and maintenance of the PV risk-based strategy, including assistance in the development of the annual audit plan and maintenance of the audit tool.</p></li><li><p>
Reviews and provides input into the quality sections of the Pharmacovigilance System Master File (PSMF).</p></li><li><p>
Supports regulatory inspections and external audits, when required.</p></li><li><p>
Train and mentor junior team members.</p></li></ul><p><br>
</p><p><b>Required Education, Experience, and Skills</b></p><ul><li><p>
A minimum of a Bachelor&rsquo;s degree in a relevant scientific field (Pharmacy, Life Sciences, etc.).</p></li><li><p>
Fluency in written and spoken English; additional language skills a plus.</p></li><li><p>
Minimum of ten (10) years of experience in the pharmaceutical industry or regulatory agency related to Quality Systems and Quality Assurance (e.g., clinical trial quality, pharmacovigilance, regulatory).</p></li><li><p>
Minimum of one (1) year of experience in PV auditing with EU/FDA /global regulatory requirements.</p></li><li><p>
Strong knowledge of EMA, FDA and ICH guidelines in GVP and proficiency in interpreting and applying regulatory requirements and guidelines.</p></li><li><p>
Attention to detail and ability to work independently in a virtual environment.</p></li><li><p>
Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook).</p></li><li><p>
Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization Availability to travel up to 20% of time.</p></li><li><p>
Collaboration and Partnering: Demonstrates ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills.</p></li><li><p>
Communication Skills: Strong verbal skills and experienced effective writing skills.</p></li><li><p>
Project Management: Demonstrates ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.</p></li><li><p>
Decision Making: Demonstrates skills to utilize knowledge, networks, and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.</p></li><li><p>
Business Operations/Knowledge of Field: Demonstrates knowledge of regulations. Regulatory and business trends and applies this knowledge to optimize daily activities and ensure the functional areas within Research and Development are compliant with regulations and appropriate procedures.</p></li></ul><p></p><p><b>
Secondary Job Description</b></p><p></p><p><b>
Who We Are:
</b></p><p>Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women&rsquo;s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.</p><p></p><p>
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.</p><p></p><p><b>
Search Firm Representatives Please Read Carefully</b><br>
Organon LLC, 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>
Annualized Salary Range</b></p><p></p><p><b>
Annualized Salary Range (Global)</b></p><p><b>
Annualized Salary Range (Canada)</b></p><p><b>
Please Note: Pay ranges are specific to local market and therefore vary from country to country.</b></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: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites</b></p><p></p><p><b>
Flexible Work Arrangements:</b></p><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>
Number of Openings:
</b></p>1<p><b><br>
Requisition ID:</b>R539374</p></div>

Associate Director, Pharmacovigilance Quality Assurance Auditor

Merck KGaA

<p></p><div><p>Work Your Magic with us!</p><p></p><p><br>
Ready to explore, break barriers, and discover more? We know you&rsquo;ve got big plans &ndash; so do we! Our colleagues across the globe love innovating with science and technology to enrich people&rsquo;s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.</p><p></p><p><br>
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.</p><p></p><p><b><br>
Your Role:
</b></p><p>Are you passionate about patient safety and looking to make a significant impact in the field of pharmacovigilance? An exciting opportunity has opened up with our company. We are looking to hire a Patient Safety Center Associate and Local Safety Responsible (LSR) for Egypt based locally in the country for the Patient Safety Center Africa.</p><p>
Responsibilities:</p><ul><li>
All Pharmacovigilance (PV) related tasks in Egypt where this role will be nominated as local Safety Responsible (LSR) to Egypt Health Authority.
</li><li>Collaborate with a team handling PV activity across other African countries. This is a unique opportunity to work cross-functionally at both local and global levels, driving initiatives that enhance patient safety.</li><li>
As a Patient Safety Center Associate, you will be an integral part of our regional organization, the Patient Safety Center Africa and will be responsible to ensure that individual case safety reports from the local market are appropriately processed and followed up.
</li><li>This role will be responsible for the establishment and maintenance of the marketing authorization holder &lsquo;s pharmacovigilance system while maintaining promoting and improving compliance with local regulatory requirements.</li><li>
Maintain the local PV documentation of the PV systems and perform PV training as applicable. You will contribute to local audits and inspections and will support the preparation of local Risk Management Plan and submission of local aggregate safety report where applicable.
</li><li>Monitor the local PV regulation and properly follow up on the generated activities.</li><li>
Uploading new information, updating records, necessary registrations and submissions to regulators systems with good understanding of Safety Databases.</li><li>
Implementation of PV agreements and perform the required PV activities related to Patient Data collection systems and Clinical studies.</li><li>
Collaborate closely with the Global Organizations as well as the cross-functional teams (local Management, QA, Medical Affairs, Regulatory Affairs Business Unit)</li></ul><p><b>
Who you are:
</b></p><ul><li>Bachelor Degree of Pharmacy or Medicine.</li><li>
Fluent in written and spoken local language and English.</li><li>
4/5 years in PV or in the pharma industry. Health authority experience is an advantage.</li><li>
Understand business needs, think strategically, and develop risk mitigation strategies.</li><li>
High level of dedication and a strong willingness to perform.</li><li>
You are curious, obsessed with customers and patients and act as the owner to make the right decision while keeping in mind the Company&rsquo;s best interests.</li></ul><p></p><p><b><br>
What we offer:</b> We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!</p><p></p><p><br>
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!</p></div>

Patient Safety Center Associate Manager

Merck Healthcare

<div>
 Work Your Magic with us!
 <br/>
 <br/>
 Ready to explore, break barriers, and discover more? We know you&rsquo;ve got big plans &ndash; so do we! Our colleagues across the globe love innovating with science and technology to enrich people&rsquo;s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
 <br/>
 <br/>
 United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
 <br/>
 <br/>
 <strong>
  Your Role
  <br/>
  <br/>
 </strong>
 Are you passionate about patient safety and looking to make a significant impact in the field of pharmacovigilance? An exciting opportunity has opened up with our company. We are looking to hire a Patient Safety Center Associate and Local Safety Responsible (LSR) for Egypt based locally in the country for the Patient Safety Center Africa.
 <br/>
 <br/>
 <strong>
  Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   All Pharmacovigilance (PV) related tasks in Egypt where this role will be nominated as local Safety Responsible (LSR) to Egypt Health Authority.
  </li>
  <li>
   Collaborate with a team handling PV activity across other African countries. This is a unique opportunity to work cross-functionally at both local and global levels, driving initiatives that enhance patient safety.
  </li>
  <li>
   As a Patient Safety Center Associate, you will be an integral part of our regional organization, the Patient Safety Center Africa and will be responsible to ensure that individual case safety reports from the local market are appropriately processed and followed up.
  </li>
  <li>
   This role will be responsible for the establishment and maintenance of the marketing authorization holder &lsquo;s pharmacovigilance system while maintaining promoting and improving compliance with local regulatory requirements.
  </li>
  <li>
   Maintain the local PV documentation of the PV systems and perform PV training as applicable. You will contribute to local audits and inspections and will support the preparation of local Risk Management Plan and submission of local aggregate safety report where applicable.
  </li>
  <li>
   Monitor the local PV regulation and properly follow up on the generated activities.
  </li>
  <li>
   Uploading new information, updating records, necessary registrations and submissions to regulators systems with good understanding of Safety Databases.
  </li>
  <li>
   Implementation of PV agreements and perform the required PV activities related to Patient Data collection systems and Clinical studies.
  </li>
  <li>
   Collaborate closely with the Global Organizations as well as the cross-functional teams (local Management, QA, Medical Affairs, Regulatory Affairs Business Unit)
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Who You Are
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor Degree of Pharmacy or Medicine.
  </li>
  <li>
   Fluent in written and spoken local language and English.
  </li>
  <li>
   4/5 years in PV or in the pharma industry. Health authority experience is an advantage.
  </li>
  <li>
   Understand business needs, think strategically, and develop risk mitigation strategies.
  </li>
  <li>
   High level of dedication and a strong willingness to perform.
  </li>
  <li>
   You are curious, obsessed with customers and patients and act as the owner to make the right decision while keeping in mind the Company&rsquo;s best interests.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  What we offer:
 </strong>
 We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 <br/>
 <br/>
 Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
</div>


IQVIA

<div><div><div>New Cairo, Egypt | Full time | Home-based | R1533906</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><br>
Our ever-growing <b>Lifecycle Safety Medical</b> 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.</div><div>
Associate Medical Safety Director</div><div>
Role responsibilities:</div><ul><li><div>
Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product&rsquo;s safety profile</div></li><li><div>
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</div></li><li><div>
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</div></li><li><div>
Providing medical review and contribution to Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies</div></li><li><div>
Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up</div></li><li><div>
Providing safety oversight and contribution for label development, review, and updates</div></li><li><div>
Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document</div></li><li><div>
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</div></li><li><div>
Representing safety and clinical data review findings during internal and external stakeholder meetings</div></li><li><div>
Providing medical safety support, contribution, and attendance at Safety Governance and other Meetings as needed</div></li></ul><div>
Do you have the skills, experience and qualification required for the role:</div><ul><li><div>
A medical degree from an accredited and internationally recognized medical school</div></li><li><div>
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</div></li><li><div>
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</div></li><li><div>
Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature</div></li><li><div>
Experience in Signal detection, Aggregate reports and Risk management.</div></li><li><div>
Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writing</div></li><li><div>
Ability to establish and meet priorities, deadlines, and objectives</div></li><li><div>
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</div></li><li><div>
Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed</div></li></ul><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 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></div></div><div></div>

Associate Medical Safety Director- Sponsor Dedicated

<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>


Bupa

<div><p>Job Description:</p><p><b>
Senior Internal Audit Manager - Egypt</b></p>
<p><b>Full time (40hrs per week)</b></p>
<p><b>Hybrid Working with Opportunities to Travel</b></p>
<p><b>Cairo, Egypt</b></p>
<p>Here you'll be welcomed. We champion diversity and we understand the importance of our people representing the communities and customers we serve. You'll find an inclusive environment where you can be yourself and where everyone is driven by the same purpose - helping people live longer, healthier, happier lives and making a better world.</p>
<p><b>Role Overview</b></p><p>
As part of <b>Bupa's Group function</b>, this role plays a key part in strengthening how we manage risk and internal controls across the organisation. You'll work closely with senior management teams to assess and enhance the effectiveness of their governance frameworks, ensuring they align with Bupa's strategic objectives and meet Financial Regulatory Authority (FRA) requirements. Acting as the local responsible person for Internal Audit, you'll plan and deliver audit activity, coordinate project teams, and keep your technical expertise sharp.</p>
<p>You'll provide independent, objective assurance to Management, the Board and the Audit Committee on the effectiveness of Bupa's systems of governance, risk management and internal control, in line with Global Internal Audit (GIA) and FRA standards. As a senior leader within Bupa Global, you'll oversee the Internal Audit agenda for our Africa region, working collaboratively across markets to support a world‑class global function.</p>
<p>This is an FRA‑regulated role with delegated responsibilities, subject to regulatory approval. Candidates must meet the FRA's Fit and Proper requirements, which assess professional experience, relevant certifications and personal integrity, and may involve a regulatory interview.</p>
<p>Given the visibility of <b>Group</b> Internal Audit's work, you'll be expected to deliver consistently high‑quality outputs while maintaining strict confidentiality. You'll also play a key role in developing our global capabilities through our innovative Ways of Working Programme and wider assurance activities.</p>
<p><b>You'll help us make health happen</b></p><p>
You'll bring your <b>communication, analysis, problem-solving skills </b>and<b> initiative</b> to this role to ensure high-quality outcomes that align with Bupa's strategy and applicable FRA requirements by:</p>
<p><b>Assurance Activities</b></p><ul><li>
Support the CAO - MU / Director of Internal Audit by overseeing all activities of the Internal Audit team within your region, including inputting into strategic planning, resourcing and the team budget plans and driving the strategic audit coverage of critical governance areas mandated by the FRA. This includes regular reporting to provide updates on progress of the internal audit plan delivery, upstand prompt escalation of issues.</li><li>
Lead and deliver on multiple assurance activities, overseeing timely completion to a high standard in accordance with our methodology, processes and procedures.</li><li>
Collaborate across teams to share insights, best practice and to deliver annual audit plans, whilst aligning with our strategy and goals.</li><li>
Champion data analytics and visualisation in all audit stages, enhancing insights and growing GIA's capabilities.</li><li>
Support your Director / CAO - MU to develop audit plans.</li><li>
Deliver impactful and visual reports for key stakeholders (local leadership teams, executive Risk, Audit and Board committees, as appropriate) and represent GIA as appropriate. This includes preparation of an annual audit opinion for your area of responsibility.</li><li>
Take ownership of all regulatory requirements in the remit of your role and ensure compliance, including with the requirements of the FRA and the Institute of Internal Auditors (IIA). Seek guidance if you need support understanding your regulatory requirements and immediately escalate any potential or actual breach of regulation.</li></ul>
<p><b>Stakeholder Management and Advocacy</b></p><ul><li>
Build strong relationships with key business stakeholders, understanding their business agenda and impact on assurance activities.</li><li>
Build strong relationships with BEI &amp; BES Board members, identifying and discussing priorities, issues and strategic challenges and relevant local regulatory developments as they pertain to IA.</li><li>
Advocate and educate colleagues on effective internal controls and value of Internal Audit.</li><li>
Support interactions with the FRA regarding governance, internal control, and internal audit matters.</li><li>
Balance multiple priorities by considering importance, urgency and impact on key relationships while delivering high-quality outcomes.</li><li>
Facilitate access to business data by promoting the benefits of GIA's data use to Bupa and stakeholders.</li><li>
Drive Bupa to achieve its strategic goals, bringing a disciplined and forward-thinking approach to the review and improvement of Bupa processes.</li><li>
Prioritise good outcomes for customers at the heart of what you say and do. Be courageous and speak up if you believe our products or services don't deliver what we've led our customers to expect.</li></ul>
<p><b>Key Skills needed for this role:</b></p><ul><li><b>
Fluency in both written and spoken English and Arabic is essential.</b></li><li>
Strong technical skills and an ability to deliver high quality audits compliant with FRA regulations, IIA standards and Bupa methodology.</li><li><b>
Significant </b>senior-level experience in insurance or reinsurance, capable of working independently with limited day-to-day supervision.</li><li>
Experience of being a trusted business partner in a service-orientated audit function, building strong relationships with key stakeholders and keeping a customer mindset.</li><li>
An ability to plan work and execute effectively, meet fixed deadlines, and take ownership of your team's results.</li><li>
Data analytics skills which support use of audit data to drive meaningful insights and change.</li><li>
A governance, risk and control mindset, and an understanding how Internal Audit fits into our 3 Lines model to keep Bupa safe.</li><li>
In-depth knowledge of risk management, audit methods and techniques.</li><li>
Experience of leading teams and managing people, either by overseeing audits or formal line management.</li><li>
Reputation for delivering on commitments, holding self and others accountable for performance.</li><li>
Strong communication skills and confidence in written and verbal presentation of audit results to stakeholders.</li><li>
Commercial awareness, business acumen, a good understanding of Bupa and the regulatory framework in which it operates.</li><li>
ACA, ACCA, CIMA, PIIA, CMIIA, CIA, CISA or equivalent overseas qualification is desirable. The candidate should be a chartered auditor or accountant.</li></ul>
<p><b>Bupa</b></p><p>
We're a health insurer and provider. With no shareholders, our customers are our focus. Our people are all driven by the same purpose - helping people live longer, healthier, happier lives and making a better world. We make health happen by being brave, caring and responsible in everything we do.</p>
<p>We encourage all of our people to &rdquo;Be you at Bupa&rdquo;, we champion diversity, and we understand the importance of our people representing the communities and customers we serve. That's why we especially encourage applications from people with diverse backgrounds and experiences.</p>
<p>As a Disability Confident employer, we offer a guaranteed interview for every disabled applicant who meets the minimum criteria for the job. We'll make sure you are treated fairly and offer reasonable adjustments as part of our recruitment process to anyone that needs them.</p>
<p>Time Type:</p>
Full time<p>
Job Area:</p>
Legal, Risk &amp; Audit<p>
Locations:</p>
Egypt - Cairo</div>
<br>
Additional leave, Referral programme, Health &amp; wellbeing programme, Free flu jabs, Private medical insurance, Cycle to work scheme, Private dental insurance, Company pension, Employee mentoring programme, Paid volunteer time, Gym membership, Financial planning services

Senior Internal Audit Manager - Egypt

Fresenius Medical Care

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 At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision&mdash;&ldquo;Creating a future worth living. For patients. Worldwide. Every day.&rdquo;&mdash;we work with purpose and compassion, supported by a global team of over 125,000 employees.
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 Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.
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 Our values guide how we work:
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   We Care for our patients, each other, and our communities
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   We Connect across teams and borders to deliver excellence together
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   We Commit to doing things the right way&mdash; growing with purpose and leading kidney care with integrity and innovation
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 Systems, Quality &amp; Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care&rsquo;s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide!
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 Your Responsibilities:
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   Perform all country/region regulatory activities, ensuring product conformity, safety, post-market surveillance, and alignment with corporate SysQaRa and Quality functions
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   Drive market access by preparing/adapting registration dossiers, managing submissions with consultants/TPIs, supporting due diligence, and enabling timely, compliant approvals for new and existing products
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   Act as the primary regulatory key person, providing strategic guidance, risk assessments, and updates on national/regional regulatory requirements, while ensuring internal implementation and database maintenance
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   Submitting notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
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   Monitor, evaluate and inform key internal stakeholders about applicable national and hub regulatory requirements; coordinate internal implementation and actively contribute to the development of new regulatory requirements.
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   Create and maintain local/regional registration database
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   Identify regulatory and compliance risks, propose mitigation strategies, and track CAPAs resulting from internal or TPI audits
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   Serve as PVRP or PV contact for assigned countries, interfacing with authorities, healthcare professionals, distributors, and CDS, and acting as the PV lead during audits/inspections
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   For countries acting as PVRP, preparation of CAPAs for audit findings and process deviations, collection and forwarding of AE/ADRs and completion of quarterly compliance reports; for countries acting as PV point of contact, ensure preparation of CAPAs for audit findings and process deviations by the distributor and/or consultant, follow up of necessary AE/ADR collection and quarterly compliance report preparations to be performed by the related TPIs/contractors.
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   Performing implementation and maintenance of Pharmacovigilance Agreements
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 Your Profile:
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   Bachelor&rsquo;s degree in Pharmacy, Chemistry, Biology, Bioengineering, Health Sciences, or another relevant scientific discipline
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   At least 5 years of professional experience in regulatory affairs and at least 2 years in pharmacovigilance
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   Results-driven professional with a structured approach, strong problem-solving and analytical skills, and the ability to handle pressure and prioritize effectively. Excellent communicator, independent worker, and solution-focused in achieving quality outcomes
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   Demonstrated drive for process improvement and continuous optimization
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   Solid knowledge of pharmacovigilance and pharmaceutical legislation
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   Proficient in English (spoken and written)
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 Our Offer for you:
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 There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.
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   Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
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   Individual opportunities for self-determined career planning and professional development
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   A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
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   A large number of committed people with a wide range of skills, talents and experience
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   The benefits of a successful global corporation with the collegial culture of a medium-sized company
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