Pharmacovigilance Associate (PV Associate)

About the role

Ergomed is looking for a PV Associate in Belgrade to support its pharmacovigilance activities. The role covers ICSR management and related tasks for the client and the company, and may include acting as the local contact person for pharmacovigilance (LCPPV) and the person responsible for local screening (PRLS) for a specified country and language.

Key responsibilities

• Process Individual Case Safety Reports (ICSRs) from all sources in line with regulations, company procedures and client requirements and timelines
• Carry out ICSR follow-up
• Handle SAE/SUSAR management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
• Perform clinical and partner reconciliation
• Handle product quality complaints and interact with Quality Assurance and Medical Information
• Apply MedDRA and WHO coding
• Support PV processes within the company and for clients; more senior colleagues may assign tasks to junior positions according to SOPs
• Support the RA & PV Network Department as needed, including as LCPPV and PRLS for the agreed country and language

Required profile

• Graduate in life sciences, pharmacy, nursing or another healthcare-related field, or experience in pharmacovigilance
• 0-1 years of pharmacovigilance experience is desirable but not required
• Advanced English (spoken and written)
• Advanced literacy in MS Office