Job Title: Executive – Pharmacovigilance & Drug Safety
Location: Ahmedabad, Gujarat, India
Job Type: Full-Time
Experience Required: 0–2 Years
Functional Area: Pharmacovigilance / Drug Safety
Company Overview
Amneal Pharmaceuticals is a global, patient-focused pharmaceutical company committed to delivering high-quality, affordable medicines. We foster a culture of diversity, inclusion, and continuous learning, enabling employees to contribute to the safety and efficacy of medicines worldwide.
Role Overview
We are seeking a Pharmacovigilance Executive to support signal detection and drug safety activities. This role involves evaluating adverse drug reactions (ADRs), preparing Drug Safety Reports (DSRs), and maintaining compliance with regulatory standards. The position is ideal for PharmD graduates or equivalent, eager to build a career in pharmacovigilance and drug safety.
Key Responsibilities
Prepare and maintain the Signal Schedule as per Standard Operating Procedures (SOPs).
Identify, analyze, and evaluate safety signals from various data sources to assess potential risks and changes to product labeling or benefit-risk profiles.
Evaluate safety information and prepare product-specific ADR sheets.
Author Drug Safety Reports (DSRs) for valid signals following SOPs.
Communicate findings from routine and ad hoc signal detection and assessment activities to stakeholders.
Contribute to cross-functional initiatives to enhance pharmacovigilance capabilities.
Stay updated on new or revised regulatory requirements and guidelines relevant to signal management.
Ensure regulatory compliance in all signal management processes regarding quality, procedures, regulations, and timelines.
Assist in the preparation and revision of SOPs, work instructions, templates, and training materials related to signal management.
Conduct trainings related to signal management activities as required.
Qualifications & Experience
Education: PharmD / Doctor of Pharmacy.
Experience: 0–2 years in pharmacovigilance or drug safety preferred.
Strong understanding of signal detection, ADR evaluation, and regulatory compliance.
Excellent analytical, organizational, and communication skills.
Ability to work independently and collaboratively within cross-functional teams.
Why Join Amneal
Contribute to drug safety and patient health globally.
Gain hands-on experience in signal detection, ADR assessment, and regulatory compliance.
Be part of a diverse, inclusive, and collaborative workplace.
Opportunities for career growth and professional development in pharmacovigilance.
Equal Opportunity Employer
Amneal Pharmaceuticals is committed to providing equal employment opportunities to all employees and applicants. We do not discriminate on the basis of caste, religion, gender, disability, or any other legally protected status.
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