Piramal Pharmacovigilance Executive Job Opening – Apply Now
Executive Pharmacovigilance Mumbai, Maharashtra, India
TRENDING JOB DESCRIPTION
Business: Piramal Critical Care
Department: Pharmacovigilance
Location: Kurla, Mumbai
Travel: Low
Job Overview: The Executive Pharmacovigilance will be responsible end-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable regulatory authorities within stipulated timelines
Key Stakeholders: Internal Quality, Sales, Supply Chain, and Regulatory Affairs teams
Key Stakeholders: External Vendors and auditors
Reporting Structure: This role reports to the Manager – Pharmacovigilance
Experience: Overall, 2-3 years of experience in Pharmacovigilance with at-least 1 year of relevant work experience in ICSR processing, Literature screening and authoring of aggregate safety reports like PADERs, PBRERs etc
Competencies:
- 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
Key Role and Responsibilities:
- End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable regulatory authorities within stipulated timelines.
- Mailbox management and tracking of incoming Individual case safety reports (ICSRs). Reconciliation of ICSRs.
- Enter and/ or submit cases to applicable regulatory authority safety databases. Perform and monitor literature for company molecules.
- Maintain and update safety logs and safety files.
- Prepare and share compliance data with QPPV.
- Provide data for compliance representation/monthly information system.
- Assist in handling of product complaints and reconciliation.
- Assist in responding to queries and requests related to safety of products and Pharmacovigilance system from regulatory authorities.
- Prepare for internal or external audits and inspections.
- Preparation/Drafting of aggregate reports (PADER and PSURs).
- Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities.
QUALIFICATIONS: B Pharm/M Pharm
Apply Now: To apply for this position and view the original notification, click here.
Keywords: Executive Pharmacovigilance, Mumbai, Piramal Critical Care, Pharmacovigilance Department, Job Posting. Piramal Pharmacovigilance Executive Job Opening – Apply Now. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
