Regional PV Manager

• Location: Morristown, NJ

About the job

The performance of the DCSH is of high importance as these roles are mandated by local legislation and within the scope of local PV inspections. The Deputy CSH must be ready to deputize for the CSH at any time and may be exposed to GxP inspections standing in the first line (e.g. unannounced inspections during a time of absence of the CSH).

At Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our ambition is to enable better self-care for individuals and communities, while also contributing to a healthier planet. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.

Main Responsibilities:

• Supports the Country Safety Head in country related PV activities.

• Deputizes for the CSH in times of planned or unplanned absence of the CSH.

• Is nominated as deputy local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations.

• Supports the CSH in ensuring that local PV activities in the assigned country are performed in compliance with the Global PV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country.

• Builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager.

​Organization and Maintenance of Local PV Quality System:

• Support the maintenance of local quality documents owned by PV to include documented reviews, gap assessments and revisions as per global requirements.

• Support the maintenance of the local PV System Master File for the assigned country as required and in accordance with local regulations and the global standards.

• Contribute to education and training on PV and relevant safety topics within the local organization.

• Maintain local compliance metrics and ensure data capture in the appropriate tools.

• Support PV process non-compliance investigation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation including appropriate documentation.

• Support the completion of audit and inspection observations in close interaction with Global /Local Function.

Organization and Maintenance of PV Operating & Safety Management System:

• 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 Global PV Operations and subsequently to external stakeholders, such as HAs, partners.

• Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with Global PV, Clinical Operations and RA departments to the planning for PSRs.

• Screen local scientific / medical literature and management of relevant abstract/articles.

• Support the implementation and monitor the PV requirements for global, regional and local programs (e.g. Patient Support Program, Market Research, Managed Access Program...), and company sponsored digital media.

• Contribute to screening and analysis of national regulations, and forward any future/new/updated PV regulation as per defined processes.

• In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), support the monitoring of the appropriate execution of outsourced activities.

• Support the Global PV and particularly the QPPV with local safety surveillance activities.

• 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) in the assigned country.

About you

• Experience: Experience with pharmacovigilance systems and safety related product management.
• Soft and technical skills: Robust understanding of national PV regulations regarding safety requirements. Pragmatic, solution-oriented mindset; problem-solving, prioritize, detail-oriented, and meet challenges. Good written and verbal communication skills. Good level of speaking/writing English.
• Education: Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master's Degree with two or more years of pharmacovigilance