Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Executive, Pharmacovigilance & Drug Safety

Amneal
Amneal
1-4 years
Not Disclosed
10 Jan. 2, 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
Employment Type: Full-Time
Job Category: Pharmacovigilance & Drug Safety
Experience Required: 1–4 Years (Signal Management / Drug Safety)
Education Required: Pharm.D / Doctor of Pharmacy
Job ID: 6996


Job Overview

Amneal Pharmaceuticals is seeking an Executive – Pharmacovigilance & Drug Safety to support its global drug safety and signal management activities. The role focuses on safety signal detection, evaluation, documentation, and regulatory compliance across the product lifecycle. This position is ideal for professionals with hands-on experience in pharmacovigilance, signal management, and regulatory safety reporting.


Key Responsibilities

  • Prepare, maintain, and update the Signal Schedule in compliance with approved Standard Operating Procedures

  • Perform identification, analysis, and evaluation of safety signals from multiple data sources

  • Assess safety data to determine potential risks impacting product labeling or benefit–risk profile

  • Review safety information and prepare product-specific ADR (Adverse Drug Reaction) sheets

  • Author Drug Safety Reports (DSRs) for validated signals in accordance with internal procedures

  • Communicate routine and ad hoc signal detection outcomes to cross-functional stakeholders

  • Support cross-functional initiatives to strengthen pharmacovigilance and signal management processes

  • Maintain up-to-date knowledge of global regulatory requirements related to signal management

  • Ensure compliance with quality standards, timelines, and regulatory expectations

  • Assist in the development and revision of SOPs, work instructions, templates, and training materials

  • Deliver training sessions on signal management activities as required


Required Qualifications & Experience

  • Education: Pharm.D / Doctor of Pharmacy

  • Experience: 1–4 years of relevant experience in Pharmacovigilance, Drug Safety, or Signal Management

  • Strong understanding of global PV regulations and signal management frameworks

  • Experience in safety data evaluation, signal detection, and regulatory documentation

  • Excellent analytical, documentation, and stakeholder communication skills


Key Skills & Competencies

  • Pharmacovigilance and Drug Safety Operations

  • Signal Detection and Signal Management

  • Adverse Drug Reaction (ADR) Analysis

  • Drug Safety Reporting (DSR)

  • Regulatory Compliance and SOP Management

  • Risk–Benefit Assessment

  • Cross-functional Collaboration


About Amneal Pharmaceuticals

Amneal Pharmaceuticals is a global pharmaceutical company committed to delivering high-quality, affordable medicines. The organization operates across multiple therapeutic areas and geographies, maintaining strong compliance with global regulatory and pharmacovigilance standards. Amneal is an equal opportunity employer and promotes a diverse, inclusive, and ethical workplace.


Workplace & Culture

Amneal fosters a culture of integrity, compliance, and continuous improvement. The organization values collaboration, regulatory excellence, and patient safety as core drivers of its pharmacovigilance and drug safety operations.


Job Details

  • Job Schedule: Full-Time

  • Degree Level: Master’s Degree

  • Work Location: Ahmedabad, Gujarat, India