Executive Sr. Executive - Drug Safety Specialist Job at Fidelity Health Services in Navi Mumbai | Jobslly

Role & Responsibilities

• Manage safety reconciliation and compliance monitoring activities for global clients
• Perform reconciliation of Reference Safety Information (RSI) for assigned products
• Conduct data mining and review of FDA Adverse Event Reporting System (FAERS) and other regulatory safety databases
• Edit, review, and reconcile consolidated global product lists
• Manage global exchange of safety information related to product approvals, launches, cancellations, and RSI updates
• Maintain and update all documents related to safety reconciliation and compliance activities
• Ensure adherence to global pharmacovigilance regulations and internal SOPs

Qualification

• B.Pharm / M.Pharm

Experience

• 5–8 years of experience in the Pharmacovigilance domain
• Hands-on experience in safety reconciliation and compliance monitoring

Skills

• Pharmacovigilance compliance & reconciliation
• FAERS database review
• Reference Safety Information (RSI) management
• Advanced MS Excel skills
• Mailbox management & documentation
• Strong analytical and communication skills

About the Company

• A global life sciences organization providing pharmacovigilance, regulatory, and compliance services across international markets