Manage and responsible for all pharmacovigilance related activities at country level to ensure compliance with Sanofi Global Pharmacovigilance and country regulation and serve as local Responsible Person for Pharmacovigilance (RPP)
AREAS OF RESPONSIBILITY
1. Management of pharmacovigilance activities at country level
Represent PV in interactions with local GxP and non GxP functions, to optimize coordination and collaboration in areas of overlapping interests : participate actively to local meetings / committees such as MRPQ meeting, be a member (permanent or Ad Hoc) of the country council
Build and 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
o Secure with Medical Information, Clinical Study Unit, Quality, Marketing and local third party (e.g. CRO, vendors) the detection and transmission to PV unit of incoming PV data in timely manner
o Contribute to the development of 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
Manage country PV budget in a cost-effective way to ensure an efficient local PV system in adherence with regulations and company policies, in liaison with the local Controller
2. Build and maintain interaction with regional and global stakeholders
Identify issues or dysfunction in the assigned country(ies) and escalate to Regions PV Head, and / or via Multi-Country Safety Head
Interact closely with Regions Process Coordination Team within Regions Governance Team
In case of local PV outsourcing activities, collaborate with GPV-Global PV management office to implement the best outsourced capabilities, with support of Regions Resources & Budget Lead
Interact with the Global Safety Officer (GSO) for any questions related to the safety profile of Sanofi product originating from HA or any other sources
Collaborate with Regions Systems & Standards Harmonization Team within Regions Governance Team and other GPV unit such as PV operations team, SDEA Team, etc.
to contribute to the appropriate management of Local PV system
Participate in working group as set up at regional or global level
3. Organization and 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 documentation of attendees and topics covered (i.
e. PV Awareness, training of service providers and manufacturing sites)
Manage of 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, Regulatory)
Complete in timely manner audit and inspection observations in close interaction with Global / Local Functions
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
4. Organization and Maintenance of PV Operating & Safety Management System
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, 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 ,
Screen local scientific / medical literature and manage relevant abstract / articles accordingly
Ensure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program.
and company sponsored digital media
Screen and analyze national regulations, and forward any future / new / updated PV regulation (draft or final) to GPV via Regulatory Intelligence unit and Region PV Head
Participate in the local business continuity plan and after hours’ emergency calls process
Ensure accurate local implementation of global Safety Data Exchange Agreements (SDEAs), when applicable.
Secure that for all local Business Partner agreements, requiring safety provisions, a local SDEA or PV Clause is set-up, implemented and maintained as appropriate.
In case of local product in-licensing or local company acquisition : participate, in close collaboration with GPV in the due diligence and integration process
In case of local outsourcing of PV activities to third parties (i.e. vendors / service providers / CROs), manage contract / work order with local service provider, monitor the appropriate execution of outsourced activities and take the appropriate measures in case of deviations
Support the GSO with local safety surveillance activities : acts as local sentinel supporting the global safety signal detection for all products in the country(ies)
Handle / escalate product safety alerts in timely manner
Contribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert
Track the actual implementation of additional Risk Minimization Measures (aRMMs)
Ensure that PV unit is involved in reviewing relevant safety sections of local documents, owned by other affiliates entities, such as labeling, contracts with third parties and local study protocols.
5. Medical safety management of local products (Local Safety Officer role) :
Responsible of the safety surveillance of assigned local products, with the support of a reference GSO in compliance with local regulations and Sanofi group procedures.
This includes (but not limited to) :
o Handling responses to Health Authorities requests,
o Development of periodic safety reports,
o Management of safety signal (detection, validation, analysis),
o Development of risk management plans,
o Label updates,
o Health hazard evaluations
o Local studies Documents
Work in close collaboration with Regions Medical Safety Head (RMSH) to ensure appropriate assessment of Safety information related to Sanofi local product
Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master Degree
Educational background :
o Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master Degree
o Other medical or scientific university educational background may be considered if the candidate has strong experience and other country staff can act as Local Safety Officer.
o Business degree, e.g. MBA, is a plus.
Years of experience and in what field :
Two or more years of pharmacovigilance / clinical development / medical / regulatory affairs / clinical practice experience
Special skills and credentials required to do the job :
o Strong knowledge and expertise in national (pharmacovigilance) regulations and international regulations as well as industry standards and experience with pharmacovigilance systems and safety related product management in both clinical development and marketed products
o Appropriate experience with Regulatory Agency interactions
o Knowledge of required standards for high quality safety relevant documents, e.g. RMP, PBRER
o Generates and incorporates safety insights to shape the development and commercialization plans, and the broader regulatory environment.
o Personal leadership involves the ability to lead from the inside out. Personal leadership translates into courage, choice, and commitment through the pursuit of excellence, trust and accountability.
Prepared to give up their own interests or wishes in order to help others or advance a cause.
o Takes the lead and initiates activities with a high degree of passion and commitment. It also refers to a personal positive orientation, together with feelings of enthusiasm, zeal and confidence, as well as the drive, desire and need to achieve challenging goals, to improve performance or to meet personal standards of excellence.
o A person’s desire and ability to learn from experience, and to apply their learning to perform successfully under new or first-time conditions.
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