Senior Pharmacovigilance Associate
ICON
Senior Pharmacovigilance Associate role managing drug safety deliverables and adverse event reporting for a global healthcare organization. The position involves overseeing pharmacovigilance activities, analyzing safety data, and ensuring regulatory compliance across multiple markets.
Responsibilities
- Lead collection, evaluation, and processing of adverse event reports per regulatory guidelines
- Analyze safety data to identify trends and potential safety signals requiring investigation
- Prepare and submit periodic safety update reports and regulatory documentation
- Collaborate with medical teams to assess clinical relevance of adverse events
- Maintain pharmacovigilance database integrity and ensure data management compliance
Requirements
- Bachelor's degree in scientific or healthcare-related discipline
- Extensive pharmacovigilance or drug safety experience with regulatory knowledge
- Proficiency in pharmacovigilance databases and Microsoft Office Suite
- Strong analytical skills for complex data interpretation and signal detection
- Demonstrated ability to manage adverse event reporting independently
- Excellent cross-functional communication and collaboration abilities
- Willingness to travel approximately 15% as required
Oferta pracy dodana 23 dni temu