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Executive, Pharmacovigilance & Drug Safety

Amneal
Amneal
0-2 years
Not Disclosed
10 Jan. 1, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Executive – Pharmacovigilance & Drug Safety
Location: Ahmedabad, Gujarat, India
Job Type: Full-Time | Pharmacovigilance & Drug Safety
Job ID: 6996

About Amneal
Amneal Pharmaceuticals is a global, equal-opportunity employer committed to diversity, inclusion, and innovation. We foster a workplace where talent thrives and employees contribute to improving patient safety and healthcare outcomes worldwide.

Role Overview
We are seeking an Executive in Pharmacovigilance & Drug Safety to contribute to signal detection, risk assessment, and safety management of pharmaceutical products. The ideal candidate will have strong analytical skills and experience in monitoring, evaluating, and communicating safety signals in compliance with global regulatory standards.

Key Responsibilities

  • Prepare and maintain the Signal Schedule according to Standard Operating Procedures (SOPs).

  • Identify, analyze, and evaluate safety signals from various data sources to determine potential risks affecting product labels or benefit-risk profiles.

  • Evaluate safety data and prepare product-specific ADR (Adverse Drug Reaction) sheets.

  • Author Drug Safety Reports (DSR) for validated signals per SOPs.

  • Communicate findings from routine and ad hoc signal detection to relevant stakeholders.

  • Contribute to cross-functional initiatives to improve pharmacovigilance capabilities related to signal detection.

  • Stay updated on new or revised regulatory requirements and guidelines relevant to Signal Management.

  • Ensure regulatory compliance, including quality, timeliness, and adherence to procedures.

  • Assist in preparing and revising SOPs, work instructions, templates, and training documents.

  • Conduct trainings related to signal management activities as required.

Qualifications & Experience

  • Pharm.D. / Doctor of Pharmacy (Master’s level education preferred).

  • Demonstrated knowledge of pharmacovigilance, drug safety, and signal management processes.

  • Strong understanding of regulatory requirements and ability to ensure compliance.

  • Excellent communication, analytical, and problem-solving skills.

Why Join Amneal

  • Be part of a dynamic team driving pharmacovigilance excellence.

  • Collaborate with cross-functional teams to enhance drug safety and patient care.

  • Contribute to a workplace committed to diversity, inclusion, and continuous learning.

Location Details
2nd Floor, W-1, Behind Old Big Bazaar, Ahmedabad, Gujarat, 380058, India

Application Deadline: 02/01/2026