AbbVie Affiliate Safety Representative (ASR) and Pharmacovigilance (PV) Coordinator Adriatic Region, Quality Assurance (QA) Officer Serbia in Belgrade, United States
Affiliate Safety Representative (ASR) and Pharmacovigilance (PV) Coordinator Adriatic Region, Quality Assurance (QA) Officer Serbia
Republic of Serbia, Vojvodina, Belgrade
2 additional locations
Republic of SerbiaRepublic of Serbia, Vojvodina
Research & Development
Pharmacovigilance (ASR Serbia and PV Coordinator for distributor markets)
Quality Assurance (QA Officer Serbia, back-up for QA lead Adriatic Region)
This function is office based; Belgrade, Serbia
- ASR SERBIA AND PV COORDINATOR ADRIATIC REGIONCoordination and execution of all aspects of pharmacovigilance (drug safety) to ensure that all of AbbVie's statutory and ethical responsibilities are met. Act as the Affiliate's main contact point for pharmacovigilance matters with the National Regulatory Authority, Adriatic Affiliate Pharmacovigilance Lead and AbbVie Pharmacovigilance and Patient Safety (PPS).
Act as QA responsible person for Serbia fulfilling local regulatory requirements with respect to Product Quality Complaints and/or Recalls and conform to AbbVie standards.
Medical, pharmacy or life-sciences degree (or equivalent).
Minimum of two years' experience working in the pharmaceutical industry in a drug safety role is strongly preferred for the Affiliate Safety Representative role but is less critical for the backup QA role.
Excellent written and spoken communication and presentation skills.
Fluency in written and oral English is essential in order to facilitate communications with Pharmacovigilance and Patient Safety, Regional Medical and other headquarters functions.
Fluency in written and oral local language a requirement in order to facilitate communications within the affiliate, and with the National Regulatory Authority.
High customer orientation.
Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
Sound judgment, strong planning and organizational skills, and the ability to get things done. Demonstrated strong sense of urgency.
Travel: Yes, 5 % of the Time
Job Type: Temporary Work