Job Title: Drug Safety Specialist / Executive Safety Writer
Designation Level: Executive / Senior Executive
Location: Mumbai, Pune, India
Employment Type: Full-Time
Experience Required: 3–4 years in Pharmacovigilance
Job Overview
We are hiring an experienced Drug Safety Specialist to support pharmacovigilance operations with a strong focus on case processing, safety writing, and Safety Data Exchange Agreement (SDEA) management. The role involves close collaboration with internal stakeholders and external business partners to ensure timely safety data exchange, reconciliation, and regulatory compliance in accordance with global pharmacovigilance standards.
This position is ideal for professionals with hands-on experience in safety data exchange, partner reconciliation, and medical writing within regulated pharmacovigilance environments.
Key Responsibilities
Pharmacovigilance & Safety Operations
Manage and process Individual Case Safety Reports (ICSRs) in compliance with global pharmacovigilance regulations.
Perform safety writing activities including narratives, follow-up queries, and case documentation.
Ensure effective implementation and lifecycle management of Safety Data Exchange Agreements (SDEAs).
Partner & Stakeholder Coordination
Initiate and maintain communication with internal business teams and global subsidiaries to gather SDEA-related requirements.
Coordinate with external business partners and third parties to establish, update, and maintain SDEAs.
Conduct periodic exchange of safety data and perform adverse event reconciliations with partners.
Compliance & Quality
Ensure timely and accurate safety data exchange in line with contractual obligations and regulatory timelines.
Stay updated with evolving global pharmacovigilance regulations, technical guidelines, and scientific developments.
Support inspections, audits, and internal quality checks related to partner safety data exchange.
Required Qualifications
Educational Background: B.Pharm, M.Pharm, BAMS, or BHMS
Experience: Minimum 3–4 years of experience in pharmacovigilance, case processing, safety writing, and SDEA management
Strong understanding of global PV regulations and partner data exchange processes
Experience in conducting safety data reconciliations with business partners
Excellent written, verbal, and presentation skills
Desired Skills
Strong analytical and documentation skills
Ability to work independently in a cross-functional and partner-facing environment
High attention to detail and compliance-driven mindset
Familiarity with global regulatory standards and safety databases
Career Level
Executive – Drug Safety Specialist
Senior Executive – Drug Safety / Safety Medical Writer
Why Apply Through The Pharma Daily
Exposure to global pharmacovigilance operations and partner collaborations
Career advancement opportunities in safety writing and drug safety leadership tracks
Work with regulated environments aligned with international safety standards
Strong professional growth within life sciences and drug safety domains
Apply now to advance your career in pharmacovigilance and drug safety with a role designed for experienced safety professionals seeking global exposure.
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Canada |Quebec :
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Auckland |New Zealand :
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Croatia |Zagreb :
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Kyiv |Lima Region :
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