
Pharmacovigilance Specialist
2 weeks ago
The primary objective of this role is to monitor and report adverse drug reactions, ensuring adherence to regulatory guidelines and industry standards regarding drug safety and pharmacovigilance.
This full-time position requires a high level of attention to detail, organizational skills, and the ability to prioritize tasks effectively in order to track and document adverse drug reactions (ADRs) and ensure timely reporting to regulatory authorities.
Key Responsibilities:- Adverse Event Reporting: Track and document ADRs, ensuring they are reported to regulatory authorities in accordance with established timelines and guidelines.
- Clinical Data Analysis: Collect, analyze, and review clinical trial and post-marketing data to identify trends in drug safety, providing recommendations for risk management strategies as needed.
- Regulatory Compliance: Ensure compliance with regulatory guidelines and industry policies regarding drug safety and pharmacovigilance, collaborating with medical, regulatory, and clinical teams to ensure comprehensive drug safety reporting.
The ideal candidate will possess strong analytical and communication skills, with the ability to work effectively in a team environment and maintain accurate records.
Additional responsibilities include assessing and providing recommendations on risk management strategies for drugs, ensuring timely and accurate reporting, and maintaining accurate records. This role also requires collaboration with cross-functional teams to ensure seamless execution of drug safety initiatives.
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Amrāvati, Maharashtra, India Medpace Full timeJob SummaryWe are currently seeking a full-time office-based Clinical Safety Coordinator to join our Clinical Safety department in India This position will be focused on the handling and processing of adverse events from all sources including clinical trials and post marketing surveillance If you want an exciting career where you use your previous...