Pharmacovigilance Manager - Middle East

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LPV - Middle East (Saudi Arabia, UAE, Kuwait, Qatar, Oman, Bahrain, Iraq, Syria, Lebanon and Jordan):

• The Local Pharmacovigilance Responsible Person (LPV) is a local role, i.e., responsibility for an affiliate and, if applicable, additional countries reporting into an affiliate.
• The LPV is responsible for the review of protocols for Cosmetovigilance (CV)/ Pharmacovigilance (PV)/Medical Device Vigilance (MDV); providing guidance and advice on required and desirable CV/PV/MDV activities to ensure compliance with appropriate regulatory, institutional, and local guidelines and regulations. This is done in collaboration with Regulatory teams in Middle East Countries as well as Global Safety (GS) in headquarters in Paris.
• The LPV works to maintain the high-profile image of the company with health authorities in Middle East Countries.

The LPV supports the setup and implementation of CV/PV/MDV activities for studies, including internal and external collaborator/staff training, drafting and reviewing Standard Operating Procedures (SOPs), and ongoing review of SOPs.

The Cosmetovigilance (CV), Pharmacovigilance (PV), and Medical Device Vigilance (MDV) Manager in Middle East countries (Saudi Arabia, UAE, Kuwait, Qatar, Oman, Bahrain, Iraq, Syria, Lebanon and Jordan) is responsible for ensuring, at a minimum, the following:

1. Local Pharmacovigilance System Set Up

• Coordinate and organize, at the national/area level and in liaison with the Global Safety (GS), all activities in relation to the oversight on the safety profile of the portfolio.

2. Local Qualified Person for Pharmacovigilance (QPPV)

1. • Act as the nominated person (or local QPPV) for the local competent authority if and as required by local regulations.

3. Management of Pharmacovigilance (PV) Cases

1. • Manage PV cases from all sources as per internal procedures.
   • Collect, review, and follow-up on local ICSRs brought to the attention of the staff of Servier local structure or from other sources, and transmit the information to GS after analysis and completion.
   • Collect, review, and follow-up on SADRs for named patient products (i.e., compassionate use) and transmit to GS.

4. PSMF Maintenance

1. • Maintain the Pharmacovigilance System Master File (PSMF) as applicable according to local regulatory requirements.

5. Literature Surveillance

2. • Ensure literature screening in local scientific journals and perform case processing for identified ICSRs as per internal procedures.

6. Management of Key Interfaces

3. • Ensure oversight and periodic reconciliation on interfaces that are potential sources of PV cases.

7. Study and Program Oversight

4. • Ensure appropriate safety reporting processes are in place at the affiliate level and described in relevant local documents for global and local interventional and non-interventional studies and Compassionate Use according to Global processes and local regulatory authority requirements.

8. Management of Aggregate Reports

1. • Provide safety-related and country specific information to Global teams for the preparation of Aggregate Reports when necessary.
   • Maintain an Aggregate Report tracking table with evidence of submission and compliance metrics.
   • Ensure submission of Aggregate Reports (as applicable) to local regulatory authorities in accordance with global processes and local regulatory authority requirements.

9. Oversight of Risk Management Plan (RMP) and Additional Risk Minimization Measures (RMM) Implementation

2. • Ensure oversight of RMP implementation in collaboration with relevant staff in accordance with GS and local regulatory authority requirements.
   • Follow up on the distribution of additional RMM locally and its compliance metrics.
   • Submission of RMPs and aRMMs to Regulatory authority, when applicable.

10. Signal Detection

1. • Ensure local signal detection activities and communicate any potential local safety signals detected during routine pharmacovigilance activities to Global Safety.
   • Oversee the signal evaluation report posted in the WRA Portal from Global Safety.
   • Ensure country specific obligations (local appendix) are submitted.

11. Safety Communication and Responses to National Competent Authority Requests

2. • Ensure safety queries, other significant safety issues, and, if applicable, local/global crisis management are performed according to Global processes and local regulatory authority requirements.
   • Maintain oversight of any safety communication to Healthcare Professionals or consumers as applicable.
   • Provide the EEA-QPPV office with all relevant information to allow their oversight and follow up on requests from the EEA-QPPV office as applicable.
   • Stay updated with local regulations.

12. Labelling and Commitments

1. • Ensure awareness and contribute (as applicable) to local safety label updates in collaboration with Local Regulatory Affairs as applicable.
   • Contribute to the implementation of commitments, when applicable.

13. Pharmacovigilance Quality System

2. • Implement and maintain a local Pharmacovigilance Quality System in accordance with Global processes and local regulatory authorities' requirements.
   • Assume responsibility for educating and training relevant personnel in the affiliate and Business Partners or Service Providers, when applicable, and maintain local training records and compliance metrics.
   • Conduct monthly reconciliation of product quality complaints, falsified medicinal products, and medical inquiries with local teams, business partners, service providers, and other external stakeholders to ensure all safety information is accurately captured.

14. Local Pharmacovigilance Agreement

1. • Participate in the negotiation and writing of local pharmacovigilance agreements with local partners or service providers.
   • Inform the Global Safety International Unit beforehand on all contracts set up locally regarding pharmacovigilance activities and/or which have an impact on pharmacovigilance activities.
   • Ensure compliance with agreements.
   • Provide timely feedback to the Global Safety International Unit on all changes the LPV is aware of (e.g., change in products concerned by the pharmacovigilance agreement).

15. Business Continuity

2. • Ensure continuity of pharmacovigilance activities at the local level, including the setup of a system to cover out-of-business hours.

16. Regulatory Intelligence

1. • Continuously screen for updates of local legislation, perform impact analysis, and inform Global Safety of any changes.

17. Archiving

2. • Ensure that PV documents are archived in accordance with local regulatory requirements and data protection rules, as applicable.

18. Audit and Inspection

3. • Inform Global Safety as soon as a notification of an audit by a Business Partner or inspection is received and ensure the local contact point.
   • Ensure the CAPA plan implementation within the defined timelines.

The tasks listed above are not exhaustive, and additional tasks may be assigned based on business needs.

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognised for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.