Senior Manager - Pharmacovigilance Operations

Bharat Serums and Vaccines Limited; Navi Mumbai; On-site; INR 1,500,000 - 2,000,000; Full time

Job summary

A leading pharmaceutical company in Navi Mumbai is seeking a Senior Manager - Pharmacovigilance Operations. The candidate will oversee the preparation of reports and quality assurance in compliance with regulations. With a requirement of approximately 12 years of experience and a Pharmacy degree, this role focuses on regulatory knowledge and team leadership in a fast-paced environment.

Qualifications

• Approx. 12 yrs of experience in Pharmacovigilance.
• Post-Graduation is preferred.
• Understanding of Pharmacovigilance requirements in India.

Responsibilities

• Prepare aggregate reports and conduct quality reviews.
• Ensure regulatory compliance of reports.
• Develop PV training modules.

Skills

Pharmacovigilance experience

Cross-functional collaboration

Line management

Regulatory knowledge

Quality management

Education

Pharmacy degree

Post-Graduation

Job description

Senior Manager - Pharmacovigilance Operations

Direct message the job poster from Bharat Serums and Vaccines Limited

• 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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Other

Industries

• Pharmaceutical Manufacturing