Job title: Senior Pharmacovigilance Manager / Pharmacovigilance Officer in Charge
Company: Sanofi
Job description: The Country Safety Head back-up (CSH back-up):
Is in charge for India
Replaces the CSH in most of his/her tasks when he/she is out of the office, including acting as local PV contact for the authorities and being accountable for PV inspections
Supports the CSH to:
Ensure that local PV activities are performed in compliance with the GPV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of Sanofi products on the market in the assigned country(ies)
Establish and maintain a robust and efficient local PV system by ensuring the availability and implementation of proper systems/procedures, tools and training
In addition to his/her CSH back-up role, the CSH back-up acts as Local Safety Officer (LSO) and as such manage the medical safety of assigned GPV local products under the supervision of the Regions Medical Safety Head (RMSH.
As local Responsible Person for Pharmacovigilance (RPP) / local Qualified Person for Pharmacovigilance (QPPV) back up xxx
The CSH back-up must demonstrate sufficient proficiency in English (verbal and written) to accurately communicate PV information outside his/her country.
Competencies
Strong knowledge and expertise in international and national (Pharmacovigilance) regulations as well as industry standards
Sufficient ability to interpret clinical data including safety data
Interpersonal skills of diplomacy and team player dynamics; knowledge of and respect for cultural differences; professionalism and mediation are important
Demonstrate problem solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in QDs, Operational Manuals and Guidance documents. Capacity to work under pressure
Ability to work in international and transversal teams
Formal Education And Experience Required:
MBBS, B.Pharm, M.Pharm, Pharm D – 6 years of experience in core PV Operations .
Experience
Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products is highly recommended
A minimum of experience in either pharmacovigilance or regulatory or quality or medical or clinical development is necessary
Experience on required standards for high quality safety relevant documents, e.g. RMP, PBRER is a plus
Experience with Regulatory Agency interactions .
RANK
MAJOR DUTIES & RESPONSIBILITIES: Briefly describe the major duties and responsibilities for which the job is held accountable (what the job does, why is it done/impact)
Serves as the CSH back-up for the products of all applicable Sanofi entities for countries XX
Replaces the CSH in most of his/her tasks when he/she is out of the office, including acting as local PV contact for the authorities and being accountable for PV inspections
Local, Region and Global Partnership
Local:
In collaboration with the 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(ies) and escalate to CSH, and in absence of CSH, to Multi-Country Safety Head / 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 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 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 SMEs
Supports the 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/medical literature and forward the relevant abstract/articles to GPV
Ensure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient 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
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)
Ensures that any safety-related questions received from local Health Authorities and any local safety issues are raised and managed in timely manner
Handle/escalate product safety alerts in timely manner
Ensure development of local RMP, when applicable, with the support and validation of the Risk Management Expert
Contribute to the preparation and local implementation of additional Risk Minimization Measures (aRMMs) in collaboration with other functions (Regulatory Affair, Medical), including tracking in appropriate tool
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
Depending on outsourcing status of above activities, adjust and execute his/her responsibilities, including his/her operational oversight,
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
Medical safety management of GPV local products (Local Safety Officer role)/(in absence of Local Safety Officer):
Responsible of the safety surveillance of assigned GPV local products in compliance with local regulations and Sanofi group procedures. This includes (but not limited to):
Handling responses to Health Authorities requests,
Development of periodic safety reports,
Management of safety signal (detection, validation, analysis),
Development of risk management plans,
Label updates,
Health hazard evaluations,
Ensure appropriate Literature screening (Global and Local journals)
Local studies documents…
Work in close collaboration with RMSH to ensure appropriate assessment of safety information related to GPV local products
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Expected salary:
Location: Mumbai, Maharashtra
Job date: Wed, 07 Sep 2022 22:10:36 GMT
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