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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
Application Deadline: 02/01/2026

About Amneal

Amneal Pharmaceuticals is a global, patient-focused pharmaceutical company committed to delivering high-quality, affordable medicines. We foster a workplace that values diversity, inclusion, and continuous professional development, enabling employees to thrive while making a meaningful impact on patient safety.

Role Overview

Amneal is seeking an Executive in Pharmacovigilance & Drug Safety to support signal detection, risk assessment, and regulatory compliance across marketed and clinical products. This role is ideal for candidates with a strong foundation in drug safety, regulatory guidelines, and signal management.

Key Responsibilities

  • Prepare and maintain the Signal Schedule in alignment with Standard Operating Procedures (SOPs).

  • Identify, analyze, and evaluate safety signals from multiple data sources to determine potential risks affecting the benefit-risk profile of products.

  • Evaluate safety information and prepare product-specific ADR (Adverse Drug Reaction) Sheets.

  • Author Drug Safety Reports (DSRs) for validated signals according to SOPs.

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

  • Contribute to cross-functional initiatives to enhance pharmacovigilance capabilities related to signal management.

  • Maintain awareness of new or revised regulatory requirements and guidelines applicable to signal management.

  • Ensure regulatory compliance for signal management processes, including quality, timeliness, and procedural adherence.

  • Assist in the preparation or revision of SOPs, work instructions, templates, and training materials for signal management.

  • Provide training on signal management activities to relevant teams as required.

Qualifications & Experience

  • PharmD (Doctor of Pharmacy) required.

  • Strong knowledge of pharmacovigilance regulations, signal detection methodologies, and adverse event reporting.

  • Demonstrated ability to analyze safety data and communicate actionable insights to stakeholders.

  • Familiarity with regulatory compliance, SOP development, and cross-functional collaboration.

Why Join Amneal

  • Contribute to patient safety and drug risk management at a global pharmaceutical company.

  • Work in a collaborative environment that values professional growth and continuous learning.

  • Join a diverse, inclusive, and forward-thinking team focused on healthcare innovation.

Location: 2nd Floor, W-1, Behind Old Big Bazaar, Ahmedabad, Gujarat, 380058, India
Job Schedule: Full-time

Category: Pharmacovigilance & Drug Safety | Master’s Degree Preferred