PV (Pharmacovigilance) Manager

[Mission]

As the Local Pharmacovigilance Responsible Person (LPV),  responsible for Korea affiliate and, ICTR Korea and Taiwan.

• The PV Manager ensures that collection, reporting and handling of safety information associated with Servier products is organized and performed according to global Servier and local regulatory requirements.
• The PV Manager maintains oversight of safety risk management and all other pharmacovigilance activities and ensures pharmacovigilance compliance and inspection readiness across all affiliate functions.

[Job Information]

• Line reporting : Head of Clinical Operations Korea
• This role manages one direct report.

[Responsibilities]

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 with the oversight on the safety profile of the portfolio.

2. Local Qualified Person for Pharmacovigilance (QPPV)

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

3. Management of Pharmacovigilance (PV) Cases whatever the sources as per internal procedures.
4. Management of key interfaces

• • Ensure the oversight and periodic reconciliation on interfaces which are a potential source of PV cases.

5. Study and Program Oversight

• • Ensure appropriate safety reporting processes are in place at affiliate level and, if applicable, described in relevant local documents, for global and local interventional and non-interventional studies and Compassionate Use in accordance with Global processes and local regulatory authority requirements.

6. Management of Aggregate Reports

• • Provide safety related information to Global teams for the preparation of Aggregate Reports, when necessary.
  • Ensure the writing of local format Aggregate Reports, when applicable, in collaboration with Global Safety Periodic Report Unit.
  • Ensure maintenance of 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 authorities requirements.

7. Oversight of Risk Management Plan (RMP) and additional Risk Minimization Measures (RMM) Implementation

• • Ensures oversight of RMP implementation in collaboration with relevant staff in accordance with GS and local regulatory authority requirements.
  • Ensures the follow-up of the additional RMM distribution locally and its compliance metrics.            

8. Safety Communication and responses to National Competent Authority requests

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

9. Pharmacovigilance Quality System

• • Ensure the implementation and maintenance of 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 also Business Partners or Service Providers, when applicable, and maintains local training compliance metrics.

10. Local Pharmacovigilance Agreement

• • Participate to the negotiation and writing of local pharmacovigilance agreement with local partners or services providers.
  • Inform the Global Safety International Unit before hands on all contracts that are set up locally regarding pharmacovigilance activities and/or which have an impact on pharmacovigilance activities (any contract with a partner company for subcontracting of specific pharmacovigilance activities).
  • Ensure oversight of local Business Partners or Service Providers and compliance with contractual agreements.
  • On a timely manner, provides 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).

11. Management of the local pharmacovigilance unit (staff and activities) as applicable

• • Lead a team of motivated individuals and promotes pharmacovigilance standards across the organization.
  • Ensure pharmacovigilance activities are properly resourced.

12. Countries under responsibility

• • Pre-marketing (clinical trial) PV activities: South Korea, Taiwan
  • Post-marketing PV activities: South Korea

[Requirements]

• Registered Pharmacist MUST 
• 10 years of experience in Pharmacovigilance (PV) within the pharmaceutical industry (MNC Pharma preferred)
• Highly responsible, independent, proactive, and strong in communication skills
• Proven collaboration experience & interaction with global & local teams
• Ability to establish and maintain open relationships within the organization and with authorities
• Demonstrable knowledge of all local requirements and of global aspects of product safety
• Experience of team management is preferred
• Fluency in English
• Good IT experience: pack office and internal tool