Менеджер по фармаконадзору

Functions:
· Collect, record, and process Adverse Event reports in alignment with company standard
operating procedures.
· Conduct local literature surveillance to identify potential safety signals.
· Ensure timely informing on AE reports to Local Regulatory Agency in a timely and legally
established way.
· Maintain and update local and global Pharmacovigilance databases.
· Monitor and interpret PV regulatory changes within the REU region.
· Prepare and submit Periodic Safety Update Reports according to local regulations and
in compliance with company processes.
· Prepare and submit safety monitoring reports in frame of National renewals and EAEU
procedures.
· Deliver regular PV training sessions for affiliate team.
· Collaborate with sales and technical teams in preparing and providing feedback for AE reports
from customers.
· Draft and finalize Pharmacovigilance Agreements.
· Contribute to regional and local PV initiatives and projects.
· Updating PV SOPs
Requirements:
· Minimum Qualification (education, experience and/or training, required certifications):
· Degree in Pharmacy, Medicine, Veterinary Medicine, or Biochemistry.
· 3 years in Pharmacovigilance (PV).
· Deep understanding of local Pharmacovigilance regulations.
· Exceptional written and verbal communication skills.
· Fluency in English.
Conditions:
· Competitive salary & annual bonus
· Medical and life insurance
· Meal allowance
· Mobile allowance