Pharmacovigilance Manager

JOB SUMMARY

The Pharmacovigilance (PV) Manager will have oversight of outsourced markets in Asia and a backup to the Singapore Country Safety Head. A liaison between global PV function and outsourced partners, this role will develop, implement and maintain the Safety Data Exchange Agreement (SDEA) and to ensure PV requirements for Sanofi products are in place.

This role will also support the Singapore Country Safety Head in PV activities and ensure they are performed in compliance with both global, regional and local PV regulations to warrant safe and appropriate use of Sanofi products. Through this role, you will collaborate with in
- country functions to position PV as a key partner, bringing value and contributing to the success of the organization.

MAIN RESPONSIBILITIES

For the outsourced countries, supports the MCSH/CSH in:

• Ensures a SDEA is set-up, implemented and maintained as appropriate
• Builds close collaboration with PV function in outsourced business partner to ensure adequate oversight is maintained and pharmacovigilance requirements for Sanofi products in place for PV data exchange, local periodic reporting, local RMP and additional Risk Minimization Measures
• Acts as a liaison between outsourced business partner and global PV functions to ensure information flow between parties

Local, Region and Global Partnership

Local:

• Act as CSH back-up including acting as local PV contact for the authorities and for PV inspections in the absence of CSH.
• In collaboration with the MCSH/CSH, maintain robust collaboration/interaction with the in-country partner functions, to carry out and monitor local PV activities, in compliance with PV regulatory requirements and company procedures/guidelines, and particularly
• Secure with Medical Information, Clinical Study Unit, Quality and Marketing and local third party (e.g. CRO, vendors) the detection and transmission to PV unit of incoming PV data in timely manner
• Contribute to develop local implementation plan of additional Risk Minimization Measures (aRMMs) and enable its implementation by working cross-functionally with Country GBU Medical Head (or delegate), the Country Regulatory Manager and other appropriate functions

Region/Global:

• Identify issues or dysfunction in the assigned country and escalate to MCSH/CSH, and in absence of MCSH/CSH, to Regions PV Head and/or directly to the QPPV
• Interact closely with Regions Process Coordination Team Regions Systems & Standards Harmonization Team and with Regions Governance Head, when needed
• In case of PV outsourcing activities, collaborate with Regions Resources & Budget Lead in Global PV management office to implement the best outsourced capabilities
• Refer to the Global Safety Officers (GSO) for any questions related to the safety profile of Sanofi product originating from HA or any other sources
• Collaborate with other GPV unit such as PV Operations Team, PV Agreements Team, etc. to contribute to the appropriate management of Local PV system

Supports the MCSH/CSH in the maintenance of local PV Quality system:

• Establish and implement processes in compliance with regional/local PV regulations and global Sanofi group procedures and cooperate with the CQH to document them in local Quality Documents as appropriate
• Develop and maintain the local PV System Master File in accordance with the global standards
• Ensure that education and training on PV and relevant safety topics within the local organization are performed including the documentation of attendees and topics covered (i.e. training of service providers and manufacturing sites)
• Manage local compliance metrics generation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation and related tracking activities
• Warrant inspection readiness of the local PV system (auditable trail of all PV activities performed locally is maintained and readily available) with key stakeholders (i.e. Quality, Medical and Regulatory)
• Complete in timely manner audit and inspection observations CAPAs in close interaction with Global/Local Function.
• Responsible of the oversight of its local PV activities through completion of periodic reports (e.g. PV Activity Report) and providing this oversight to the Region PV Head and GPV SMEs

Supports the MCSH/CSH in the maintenance of PV Operating & Safety Management:
In compliance with PV regulatory requirements and company procedures/guidelines,

• Monitor continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to GPV/Global PV entities and external stakeholders, such as HAs or partners
• Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with GPV, CSU and RA departments to the planning for PSRs
• Ensure appropriate screening local scientific/me