Senior Drug Safety Associate (Pharmacovigilance)

About the role

ICON, a global healthcare intelligence and clinical research organisation, is looking for a Senior Drug Safety Associate to join its team in Sofia, Bulgaria, on a hybrid basis. The role ensures the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities, working with cross-functional teams to meet regulatory requirements and protect patient safety.

Key responsibilities

• Lead the collection, evaluation and processing of adverse event reports so they are reported accurately and on time according to regulatory guidelines and company policy.
• Set up, maintain and close out studies as a PV Lead, write Safety Management Plans, run PV budget reviews and attend client meetings.
• Train and mentor junior team members on pharmacovigilance processes, regulatory requirements and best practices.
• Take part in regulatory authority audits and inspections, ensuring readiness and compliance.
• Stay up to date with evolving regulatory guidelines and industry best practices.

Required profile

• Bachelor's degree in life sciences, pharmacy, nursing or a related field; an advanced degree is preferred.
• Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards.
• Proven ability to manage the pharmacovigilance process, including adverse event reporting and signal detection.
• Strong analytical and critical thinking skills, and excellent communication and teamwork skills.
• Ability to work independently and manage several priorities in a fast-paced environment, with discretion over confidential patient information.
• Legal right to work in the country where the role is based.

Required skills

• Proficiency in pharmacovigilance databases and data management systems.
• Microsoft Office Suite.

What we offer

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable.
• Retirement and pension plans, life assurance and disability coverage.
• Employee assistance programmes and learning and development opportunities.