Senior 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 :

Approx. 12 yrs of experience and Pharmacy degree, Post-Graduation is preferred.

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.