Pharmacovigilance Specialist (Medical/Clinical Safety)

About the role

Biomapas is looking for a Pharmacovigilance Specialist (Medical/Clinical Safety) to join its global Pharmacovigilance team. The specialist ensures compliance with the Quality Management System and takes part in collecting, reviewing, processing and reporting safety information in line with global and local regulations, Biomapas' standard operating procedures and guidelines. The position is open in any EU country.

Key responsibilities

• Process ICSRs and Serious Adverse Events from clinical trials, including database entry, tracking, narrative writing, follow-up requests, quality checks and reporting to clients or agencies
• Reconcile safety data and take part in project and study team meetings as the safety and pharmacovigilance representative
• Oversee the planning, coordination and quality review of aggregate safety reports and support regulatory documents such as DSURs and 6MLL
• Supervise local handling of Periodic Safety Update Reports, Risk Management Plans and risk minimisation activities
• Collaborate with medical and safety physicians, data management, IT and other functions to deliver reports on time
• Act as the 24/7 local contact or backup for pharmacovigilance at local level and monitor national and regional regulations
• Handle medical enquiries by phone, email or fax, support weekly literature reviews and continuous safety profile monitoring, including signal detection
• Take part in inspections and audits, including post-inspection support

Required profile

• University degree in the life sciences
• At least 4 years of experience in pharmacovigilance, clinical safety and clinical development
• Expert knowledge of pharmacovigilance legislation and ability to apply global drug safety regulations
• Fluent English and the local country language
• Eager to adopt automation and new technologies, with attention to detail, time management and problem-solving skills
• Project management experience is beneficial

Required skills

• Knowledge of ICH, EU GVP modules and FDA regulations
• Experience with PV databases (e.g. Argus, ArisG) and MedDRA coding

What we offer

• Professional growth and career opportunities within an international team
• Bonus based on annual performance
• Personal accident and business trip insurance, additional health insurance and remote/home-based work
• Rewarding referral policy, workplace establishment allowance and team building events