Amneal Pharmaceuticals is seeking a skilled Executive in Pharmacovigilance & Drug Safety at its Ahmedabad facility. This role is perfect for M.Pharm graduates passionate about signal detection, adverse drug reaction analysis, and regulatory compliance. Join a dynamic team contributing to patient safety and enhancing the benefit-risk profile of pharmaceutical products.
Key Responsibilities
- Prepare and maintain the Signal Schedule as per SOPs.
- Identify, analyze, and evaluate safety signals from multiple data sources to assess potential product risks.
- Prepare product-specific ADR (Adverse Drug Reaction) Sheets.
- Author Drug Safety Reports (DSRs) for validated signals.
- Communicate findings from routine and ad hoc signal detection activities to stakeholders.
- Contribute to cross-functional initiatives to improve pharmacovigilance capabilities.
- Stay updated with regulatory requirements and guidelines relevant to signal management.
- Ensure compliance with quality standards, regulations, and SOPs.
- Assist in preparation or revision of SOPs, work instructions, templates, and training materials.
- Conduct training sessions on Signal Management activities when required.
Required Skills & Qualifications
- M.Pharm is mandatory.
- Expertise in Adverse Event Reporting & Signal Detection (Advanced).
- Strong skills in Safety Data Analysis & Visualization (Advanced).
- Competence in Regulatory Medical Writing, Literature Review, and Regulatory Affairs Collaboration (Intermediate).
- Strong attention to detail, communication, and cross-functional collaboration abilities.
Benefits
- Work with a leading pharmaceutical company focused on patient safety.
- Opportunity for career growth in pharmacovigilance & drug safety.
- Exposure to regulatory processes and global best practices.
- Diverse and inclusive workplace fostering innovation and learning.
How to Apply
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