Executive Job at Ameal Pharmaceuticals | MPharm Graduates Apply Online
Join the Drug Safety Job in Amneal Pharmaceuticals as an Executive in Pharmacovigilance & Drug Safety and play a vital role in ensuring drug safety and regulatory compliance. This role involves managing signal detection, analyzing safety data, authoring Drug Safety Reports (DSRs), and collaborating across teams to strengthen pharmacovigilance practices. This Pharma Job is ideal for M.Pharm professionals with advanced skills in safety data analysis, regulatory collaboration, and adverse event reporting, this is your chance to make an impact in global drug safety operations.
- Job Post: Executive – Pharmacovigilance & Drug Safety Job
- Location: Ahmedabad City, Gujarat, India
About Amneal Pharmaceuticals:
Amneal Pharmaceuticals is a global, integrated specialty and generic pharmaceutical company headquartered in Bridgewater, New Jersey, with strong manufacturing and R&D operations in India. Founded in 2002, the company is dedicated to improving patient access to high-quality, affordable medicines across diverse therapeutic areas such as neurology, oncology, cardiology, and infectious diseases. Amneal combines scientific innovation, advanced manufacturing, and a patient-first approach to deliver reliable healthcare solutions worldwide. With a growing global presence and commitment to excellence, Amneal continues to drive innovation that enhances lives and promotes better health outcomes.
Job Description:
- Prepare and maintain the Signal Schedule as per Standard Operating Procedures (SOPs).
- Identify, analyze, and evaluate safety signals from various data sources to determine potential risks affecting product labeling or benefit-risk profiles.
- Evaluate safety information and prepare product-specific Adverse Drug Reaction (ADR) sheets.
- Author Drug Safety Reports (DSRs) for valid signals as per SOPs.
- Communicate findings from routine and ad hoc signal detection and assessment activities to stakeholders.
- Contribute to cross-functional initiatives aimed at improving pharmacovigilance capabilities related to signal management.
- Stay updated on regulatory requirements and guidelines relevant to signal management.
- Ensure full regulatory compliance with respect to quality, procedures, timeliness, and documentation.
- Assist in the preparation and revision of SOPs, work instructions, templates, and training documents concerning signal management.
- Conduct and deliver trainings related to signal management activities when required.
Skills Required for the Pharma Job:
- Regulatory Medical Writing: Intermediate
- Medical Literature Review & Analysis: Intermediate
- Adverse Event Reporting & Signal Detection: Advanced
- Regulatory Affairs Collaboration: Intermediate
- Safety Data Analysis & Visualization: Advanced
Qualifications:
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M. Pharm required
