Manager - Pharmacovigilance Operations

- Preparation of aggregate reports including: PSUR, PBRER, PADER, DSURs, ACOs. - Conduct quality review of aggregate reports, and quality review of reports generated by the vendor - Ensure all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements. - Prepare data listings from the global safety database, where system access has been granted. - Collate and provide data for RMP development and Signal Detection. - Maintain and manage calendar for RMP and Signal detection. - Provide data for internal compliance meetings, monthly report and for inclusion in the PSMF as required - Raise deviations to PV processes where identified - Participate in development of CAPA and take ownership of CAPA completion where assigned - Developing Pharmacovigilance (PV) training modules and organizing PV training for PV team members and other relevant staff. - Collection of AE reports and other pharmacovigilance relevant data. - Management of PV database. - Ensuring the necessary quality, including the correctness and completeness of pharmacovigilance data. - ICSR processing specifically reviewing MedDRA coding of data, assessment in terms of diagnosis and/or seriousness, Causality and seriousness assessment. Monitoring timely submission to regulatory authority. - Literature search to identify relevant adverse event cases. - Preparation/review of contractual arrangements with other persons/organizations with regards to pharmacovigilance obligations - SDEA initiation with new parties and renewal. - Assessing safety data and proposing risk minimization measures. - Preparation/update/review of SOPs, PSURs, RMPs, contractual agreements etc. - Review of compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance. - Quality Management System: Oversee pharmacovigilance QMS and compliance activities for presentation at monthly compliance meeting and inclusion in monthly report as necessary. - PSMF: Oversee the process for PSMF creation, review and update in conjunction with the Quality & Compliance Lead, and Regional Heads as key content contributors

Requisite for the role:

- 12+ yrs of experience and Pharmacy degree, Post-Graduation is preferred. - Experience working in CRO plus Pharma industry will have added advantage. - Cross function collaboration, with Medical, Regulatory and Commercial functions. - Good understanding and knowledge of Pharmacovigilance requirements in India and adequate understanding in International and Emerging countries and regions. - Line Management experience of Pharmacovigilance staff.