Executive – Pharmacovigilance & Drug Safety
Location: Ahmedabad City, Gujarat, India
Job Description:
Roles & Responsibilities:
Prepare and maintain the Signal Schedule in alignment with Standard Operating Procedures (SOPs).
Identify, analyze, and evaluate safety signals from various data sources to determine potential risks that may require changes in product labeling or benefit-risk profiles.
Evaluate safety data and prepare product-specific Adverse Drug Reaction (ADR) sheets.
Author Drug Safety Reports (DSRs) for valid safety signals in accordance with SOPs.
Communicate key findings from routine and ad hoc signal detection and assessment activities to relevant stakeholders.
Contribute to cross-functional initiatives aimed at enhancing pharmacovigilance capabilities related to signal detection and assessment.
Stay updated on new or revised regulatory requirements and guidelines relevant to signal management.
Ensure regulatory compliance for the Signal Management process, including adherence to quality standards, SOPs, and timelines.
Assist in the preparation and revision of SOPs, work instructions, templates, and training materials related to signal management.
Deliver training sessions on Signal Management activities, as required.
Skills Required:
Adverse Event Reporting & Signal Detection: Advanced
Safety Data Analysis & Visualization: Advanced
Regulatory Medical Writing: Intermediate
Medical Literature Review & Analysis: Intermediate
Regulatory Affairs Collaboration: Intermediate
Qualification:
Bachelor’s degree in Pharmacy (B.Pharm)
About the Company:
Amneal is committed to creating a diverse and inclusive work environment. We are an equal opportunity employer and do not discriminate based on caste, religion, gender, disability, or any other legally protected status.
Estimated Salary: ₹4.5 LPA – ₹6.5 LPA (based on industry standards and role requirements)
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