Senior Pharmacovigilance Associate
On-siteSofia, Sofia-Capital, Bulgaria
Sofia, Sofia-Capital, BulgariaOn-siteFull TimeSenior LevelBachelors DegreeEnterprise
Full TimeSenior LevelBachelors DegreeEnterprise
Job Summary
Lead pharmacovigilance activities including AE report collection and processing, PSUR preparation, and regulatory submissions; oversee pharmacovigilance databases and safety data management; mentor junior team members; collaborate with medical/clinical teams on adverse events and risk management; participate in audits/inspections and maintain readiness; requires a Bachelor's degree and extensive pharmacovigilance experience; strong analytical, communication, and independent-working skills; travel about 15%; role with ICON in Bulgaria (Sofia).
Required Qualifications
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards
- Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection
- Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations
- Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams
- Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite
- Ability to work independently and manage multiple priorities in a fast-paced environment
- Willingness to travel as required (approximately 15%)
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