Job Title: Pharmacovigilance Executive

Job Type: Full-Time
Location: Kurla, Mumbai, Maharashtra
Department: Pharmacovigilance
Business Unit: Critical Care
Travel Required: No
Reporting To: Manager

Essential Qualification:

• Bachelor's or Master's degree in Pharmacy

Experience Required:

• 2–3 years of overall experience in Pharmacovigilance

• Minimum 1 year of relevant experience in:

  • ICSR processing

  • Literature screening

  • Authoring aggregate safety reports such as PADERs, PBRERs

Key Roles & Responsibilities:

• Case Management:

  • End-to-end handling of Individual Case Safety Reports (ICSRs)

  • Case receipt, follow-up, database entry, peer review, and timely submission to regulatory authorities

• Mailbox Management:

  • Manage incoming ICSRs and perform reconciliation

  • Submit cases to regulatory authority safety databases

• Literature Screening:

  • Regularly monitor literature for company molecules

• Compliance Reporting:

  • Maintain and update safety logs/files

  • Share compliance data with QPPV

  • Provide data for compliance representation and monthly information systems

• Product Safety & Support:

  • Assist with product complaint handling and reconciliation

  • Respond to regulatory queries related to product safety and PV systems

• Audits & Aggregate Reports:

  • Support internal/external audits and inspections

  • Prepare/draft aggregate safety reports: PADERs, PSURs

• Cross-functional Coordination:

  • Coordinate with stakeholders for data requests and other PV-related responsibilities

Key Competencies:

• Strong knowledge in:

  • Literature screening

  • Authoring of aggregate safety reports (PADERs, PBRERs)

• Excellent communication and interpersonal skills (written and verbal)

• Ability to handle multiple tasks and meet strict deadlines

• Strong independent working ability and team collaboration

• Proficient in Microsoft Word, Excel, and PowerPoint

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