Senior Safety & PV Specialist – Hybrid (Serbia)

About the role

Syneos Health is seeking a Senior Safety & Pharmacovigilance (PV) Specialist with experience in end‑device and medical device safety. The role is based in Serbia with a hybrid work arrangement, combining office collaboration and remote flexibility.

Key responsibilities

• Process and evaluate Individual Case Safety Reports (ICSRs) including intake, data entry, coding, and follow‑up.
• Support signal detection and signal management activities.
• Ensure compliance with global PV regulations and internal procedures.
• Manage safety information for Medical Devices (MD) and Combination Products (CP).
• Support Medical Device Vigilance (MDV) and Medical Device Reporting (MDR) activities.
• Review and process device complaints and device‑related adverse events.
• Collaborate with cross‑functional teams to ensure timely safety reporting.

Required profile

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related field.
• Proven experience in pharmacovigilance and safety case processing.
• Knowledge of ICSR handling, MedDRA coding, and global PV regulations.
• Experience with MDV, MDR, or Combination Product safety activities is highly preferred.
• Strong written and verbal English communication skills.
• Ability to work in a hybrid office setting in Serbia.

Required skills

• ICSR processing
• MedDRA coding
• Pharmacovigilance regulations
• Medical Device Vigilance
• Signal detection and management

What we offer

• Career development and progression opportunities.
• Supportive line management and inclusive culture.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Purpose‑driven environment focused on delivering impact for patients.