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Pharmacovigilance Specialist
2 months ago
We are seeking a dedicated Drug Safety Associate to join our team at PSG Global Solutions, specializing in the Biotechnology and Medical Devices sector.
Key Responsibilities:
- Independently establishes work priorities and direction with minimal guidance from management.
- Collects, documents, and processes adverse event (AE) reports from clinical trials and post-marketing sources, ensuring adherence to company Standard Operating Procedures (SOPs) and maintaining regulatory compliance.
- Prepares comprehensive clinical narrative summaries for AE reports derived from clinical studies and spontaneous post-marketing reports, while formulating follow-up information requests as necessary.
This role is essential in ensuring the safety and efficacy of our products through meticulous monitoring and reporting of adverse events.