Drug Safety Specialist (Pharmacovigilance)
Location: Mumbai / Pune, India
Job Overview
The Drug Safety Specialist is responsible for pharmacovigilance case processing, safety data exchange, and reconciliation activities with internal and external business partners. The role ensures compliance with Safety Data Exchange Agreements (SDEAs) and supports timely, accurate safety reporting in collaboration with global stakeholders.
Qualifications
B.Pharm / M.Pharm / BAMS / BHMS
Experience Requirements
3–4 years of experience in:
Case processing (pharmacovigilance)
Safety writing
Safety Data Exchange Agreement (SDEA) management
Experience in:
Safety data exchange with partners
Adverse event reconciliation
Strong awareness of pharmacovigilance regulations and industry updates
Key Responsibilities
A. Safety Data Exchange & Compliance
Initiate communication with internal stakeholders (business teams, subsidiaries) to understand SDEA requirements
Ensure Safety Data Exchange Agreements (SDEAs) are established and maintained with third-party partners
Monitor compliance with safety data exchange obligations
B. Adverse Event (AE) Management
Coordinate timely exchange of safety data with business partners
Conduct adverse event reconciliation between internal and external databases
Ensure accuracy and completeness of safety case information
C. Stakeholder Coordination
Collaborate with internal teams and external partners to ensure smooth safety data flow
Follow up with third parties for execution and maintenance of SDEAs
Support alignment between pharmacovigilance and business requirements
D. Documentation & Reporting
Maintain accurate documentation of safety data exchange activities
Support pharmacovigilance reporting and compliance documentation
Ensure adherence to internal SOPs and regulatory requirements
Core Skills Required
Pharmacovigilance case processing
Safety data exchange (SDE) systems and workflows
SDEA management and compliance
Adverse event reconciliation
Strong communication and stakeholder management
Knowledge of global pharmacovigilance regulations
Attention to detail and documentation accuracy
Soft Skills
Strong written and verbal communication
Ability to coordinate with multiple stakeholders
Proactive follow-up and issue resolution
Analytical and organizational skills
Awareness of evolving PV regulatory landscape
Work Environment
Pharmacovigilance operations and safety compliance setting
Cross-functional collaboration with global partners
High focus on regulatory adherence and data integrity
Deadline-driven operational role
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Canada |Quebec :
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Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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