Senior Associate – Pharmacovigilance (ICSR)
Location: Hyderabad, India
Experience Required: 3–4 Years
Qualification: B.Pharmacy / M.Pharmacy / Pharm.D
Position Overview
We are hiring a Senior Associate – Pharmacovigilance (ICSR) with hands-on experience in ICSR case processing and a strong understanding of global safety reporting requirements. The ideal candidate will contribute to drug safety operations, literature screening, and timely ICSR submissions in compliance with regulatory standards.
Required Qualifications
Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm) or Doctor of Pharmacy (Pharm.D)
Preferred Skills & Competencies
3–4 years of proven experience in pharmacovigilance, including:
ICSR processing (solicited & unsolicited)
Literature-based case identification
Aggregate report handling
Strong command of:
Medical terminology
Clinical pharmacology
Diagnostic and treatment procedures
Pathological investigations
Deep understanding of international PV regulations and reporting requirements.
Excellent communication skills – both verbal and written in professional English.
Strong attention to detail and analytical thinking.
Excellent organizational and time management abilities.
Capability to work independently and collaboratively within global teams.
Key Responsibilities
Perform case processing for ICSRs from various sources (solicited, unsolicited) related to:
Drugs
Devices
Vaccines
Biologic products
Cosmetics
Conduct quality control (QC) review of:
Literature searches
Individual Case Safety Reports
Ensure accurate and timely reporting of ICSRs and other safety deliverables to clients and regulatory authorities.
Maintain thorough documentation of ICSR-related activities and literature reviews in compliance with applicable SOPs.
Collaborate effectively with internal teams and clients to ensure seamless project execution.
Stay updated with evolving pharmacovigilance regulations and industry best practices.
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