Deputy Manager-Pharmacovigilance

Job Description

Business: Piramal Critical Care Department: Pharmacovigilance Location: Kurla, Mumbai Travel: No Reporting Structure Reports to: Deputy Chief Manager - Pharmacovigilance Essential Qualification Bachelors/ Masters degree in Pharmacy Experience Overall, 3-5 years of experience in Preparation and review of various safety reports, Literature screening and authoring of aggregate safety reports like PADERs, PBRERs etc. Roles and Responsibilities Preparation and review of aggregate reports (PADER and PSURs) for products approved for human and veterinary use as per applicable regulations. Draft Risk Management Plan (RMP). End to end case management, including case receipt, database entry, peer review and submission to applicable regulatory authorities within stipulated time. Perform and monitor literature for company molecules. Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities. Coordination with different stakeholders for data request etc. for fulfillment of PV related activities. Ensuring compliance with all company SOPs, procedures, and local privacy related regulations. Participating in Pharmacovigilance inspections by regulatory agencies such as FDA, MHRA and EMA. Competencies Authoring of aggregate safety reports like PADERs, PBRERs. Good communication and interpersonal skills, both written and verbal Ability to manage multiple concurrent tasks Proven ability to meet strict deadlines Ability to work independently and in a team environment Competent in use of desktop applications: Microsoft word, excel and PowerPoint