Pharmacovigilance Specialist (Специалист по фармаконадзору)

Fulfils the responsibility of affiliate safety representative for all aspects of pharmacovigilance (PV) activities to ensure that all company and Health authority PV requirements are met.

Major Responsibilities:

Adverse Event (AE) Processing:

• Ensures appropriate data collection including follow-up for postmarketing AE cases;

• Registers postmarketing and clinical AE Cases in the tracking systems;

• Submits postmarketing and clinical AEs to global company PV database, Regulatory Authorities and Ethics Committee when required;

• Submits periodic safety reports (PSUR, DSUR) and other important safety information to Regulatory Authorities as required;

• Registers PV related correspondence and maintains appropriate documentation archiving;

• Maintains quality control of safety information submitted;

• Completes AE reconciliation of Safety information received/submitted.

Training:

• Ensures timely completion of all required PV related trainings including PV regulations knowledge.

Audits and Inspections:

• Takes part in PV audits and Regulatory Authority inspections.

Safety Monitoring:

• Communicates changes to the company product risk/benefit profile to global company PV and Health Authorities when required.

Oversight of Pharmacovigilance and Compliance:

• Maintains tracking system to ensure timely submissions of required safety information to Regulatory Authority, Ethics Committees and company global PV;

• Monthly reports compliance metrics and maintains oversight of all required PV regulatory reporting compliance.

• Minimum 2 years of experience in the pharmaceutical industry in a drug safety role;

• Upper-intermediate English;

• University degree in Medicine or Pharmacy;

• Good Outlook, Microsoft Word, Excel and PowerPoint skills;

• Strong attention to detail and accuracy with orientation toward careful and meticulous work.

Key Stakeholders:

• Company global PV;

• Company affiliate employees;

• Health Authority;

• Healthcare professionals;

• Patients.