Drug Safety Specialist | Mumbai / Pune, India | Full-Time
Company Overview:
We are a leading organization in the pharmaceutical and healthcare sector, committed to patient safety and regulatory compliance. Our teams ensure timely and accurate pharmacovigilance (PV) activities, supporting global and local operations while maintaining high standards of drug safety and data integrity.
Role Overview – Drug Safety Specialist:
We are seeking a Drug Safety Specialist with 3–4 years of experience in case processing, safety writing, and SDEA management. The ideal candidate will manage the exchange of safety data, conduct reconciliations with business partners, and ensure compliance with pharmacovigilance requirements.
Key Responsibilities:
Initiate and maintain communications with internal stakeholders such as business teams and subsidiaries to understand SDEA requirements.
Coordinate with third-party vendors or business partners to ensure SDEAs are executed accurately and timely.
Manage timely exchange of safety data with partners, including reconciliation of adverse event reports.
Keep up-to-date with the latest technical and scientific developments in pharmacovigilance.
Support safety reporting processes in compliance with global and local regulatory guidelines.
Qualifications & Experience:
Education: B.Pharm, M.Pharm, BAMS, or BHMS.
Experience: 3–4 years in case processing, safety writing, or pharmacovigilance, including SDEA management.
Strong written and verbal communication skills, with the ability to present findings effectively.
Knowledge of PV processes, safety data exchange, and reconciliation with business partners.
Ability to work independently, manage timelines, and collaborate across teams.
Location: Mumbai or Pune, India
Job Type: Full-Time
Experience Required: 3–4 years
Why Join Us:
Work in a dynamic environment dedicated to drug safety and patient well-being.
Collaborate with a skilled global team and gain exposure to international pharmacovigilance operations.
Opportunities for professional growth and career advancement.
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