02 Sep
|
Opella Healthcare IN P.
|
Hyderabad
02 Sep
Opella Healthcare IN P.
Hyderabad
Job title: PV Literature Surveillance Manager
- Location: Hyderabad
About Opella
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people' s hands by making self-care as easy as it should be. For half a billion consumers worldwide – and counting.
Headquartered in France, Opella is the proud maker of many of the world' s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.
About the role
This position has responsibility to ensure overall compliance for literature surveillance on a global basis and requires comprehensive understanding of global PV regulations including but not limited to EMA and USFDA regulations.
Main Responsibilities
- PV Literature Surveillance Manager is a critical member of the PV Operations team and reports to the Global Safety Operational Group Lead.
- This position includes responsibilities for the oversight of global Literature Screening in support of ICSR, Periodic Reporting and Signal/Risk Management.
- This position is responsible for liaising with PV Operations Head to provide the strategic vision, planning and oversight of PV Literature Surveillance.
- This position maintains oversight and responsibility for Literature procurement platform.
- Responsible for the medical evaluation of complex scientific and medical literature publications encompassing all types of publications including study publications for clinical studies - for all Opella products. These publications are identified from various sources available in international literature database utilizing approved screening criteria.
- The medical evaluation of the publications ensures high medical quality and c
📌 PV Literature Surveillance Manager (Hyderabad)
🏢 Opella Healthcare IN P.
📍 Hyderabad