Chief Safety Officer

2 days ago

Mumbai, Maharashtra, India beBeePharmacovigilance Full time ₹ 5,00,000 - ₹ 8,00,000
Job Description

We are seeking a skilled professional to fill the role of Senior Executive in our organization. The ideal candidate will possess strong business acumen and be able to manage critical care functions with ease.

Key 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.

Essential Qualifications:

Bachelors/ Masters degree in Pharmacy

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.

Location: Kurla, Mumbai

Travel: No

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