Executive – Pharmacovigilance & Drug Safety
📍 Location: Ahmedabad, Gujarat, India
🏢 Company: Amneal Pharmaceuticals
🔥 Hot Job | Trending
🕒 Job Schedule: Full-time
🆔 Job ID: 6627
📅 Posting Date: 07 Oct 2025, 05:02 PM
⏰ Apply Before: 09 Oct 2025, 05:02 PM
📂 Category: Pharmacovigilance & Drug Safety
Position Summary
The Executive – Pharmacovigilance & Drug Safety is responsible for identifying, analyzing, and evaluating safety signals from various data sources to support product safety, ensure compliance, and maintain up-to-date benefit–risk profiles. The role also involves preparing drug safety reports, managing signal schedules, and contributing to continuous improvement in pharmacovigilance processes.
Key Responsibilities
Signal Detection & Evaluation
Prepare and maintain the Signal Schedule as per Standard Operating Procedures (SOPs).
Identify, analyze, and evaluate safety signals from multiple data sources.
Assess risks that could impact the product label or overall benefit–risk profile.
Evaluate safety information and prepare product-specific ADR (Adverse Drug Reaction) Sheets.
Reporting & Communication
Author Drug Safety Reports (DSRs) for validated signals in compliance with SOPs.
Communicate findings from routine and ad hoc signal detection activities to relevant stakeholders.
Participate in cross-functional initiatives to enhance pharmacovigilance and signal detection capabilities.
Compliance & Documentation
Maintain awareness of new or revised regulatory requirements and guidelines in signal management.
Ensure regulatory compliance in terms of quality, timeliness, procedures, and documentation consistency.
Assist in the preparation, revision, and maintenance of SOPs, work instructions, templates, and training materials.
Training & Development
Deliver and support training sessions related to Signal Management activities as required.
Required Skills & Proficiencies
|
Skill Area |
Proficiency Level |
|---|---|
|
Regulatory Medical Writing |
Intermediate |
|
Medical Literature Review & Analysis |
Intermediate |
|
Adverse Event Reporting & Signal Detection |
Advanced |
|
Regulatory Affairs Collaboration |
Intermediate |
|
Safety Data Analysis & Visualization |
Advanced |
Qualification
🎓 M. Pharm (Master of Pharmacy) – Required
About Amneal Pharmaceuticals
Amneal is an equal opportunity employer committed to fostering a workplace that values diversity, equity, and inclusion.
We do not discriminate on the basis of caste, religion, gender, disability, or any other legally protected status.
About the Human Resources Team
The HR team drives organizational success through strategic people management and workforce development.
Key HR Roles:
Executive Role: Strategic input and leadership in people management decisions.
Audit Role: Ensuring compliance with legal and best practice employment standards.
Facilitator Role: Supporting talent acquisition, training, performance, rewards, and wellbeing initiatives.
Consultancy Role: Advising managers on workforce and employee relations.
Service Role: Keeping the organization informed and equipped to adapt to labor market and legislative changes.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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