KEY RESPONSIBILITIES OF THE DRUG SAFETY OPERATIONS MANAGER
Oversee and manage the day-to-day activities regarding cases from marketed human and veterinary products and clinical trials,
Manage individual cases spontaneously reported to Pharmacosmos and clinical trial cases for both human and veterinary products.
Processing of Individual Case Safety Reports including Eudravigilance download, triage, data entry, coding, medical evaluation of non-serious cases, and follow-up,
Perform global and local reconciliation of ADRs with Medical Information, Quality Complaints, Affiliates, and Commercial partners,
Responsible for data retrieval for e.g. aggregate reports, signal detection, compliance, and authority requests,
Monitor individual case safety report compliance and take the necessary corrective actions locally for late reporting,
Perform World-Wide literature search,
Author, update, and review of local PV procedures,
Review pharmacovigilance agreements for inclusion of ADR exchange agreement language,
Administrator of the Global Safety Database (Basecon) including MedDRA updates, assignment of users, maintain Company Drug Dictionary, and yearly system review,
Project responsible for upcoming implementation of upgrades of the Safety Database to R3 in close cooperation with Basecon,
Contribute to preparation of audits and inspections, be member of the team that interacts with auditors/inspectors and develop Corrective and Preventative Actions (CAPAs) in response to findings/observations in close cooperation with the QPPV Office.
The position reports to Director Drug Safety.
As a professional, we expect you to:
Have a relevant scientific degree, preferably as a health care professional such as nursing,
Have experience min. 3-5 years from the life science industry in a pharmacovigilance/drug safety/safety surveillance function or maybe from the regulatory authorities/drug agencies,
Have good knowledge of PV systems and case processing,
Knowledge of the GVP modules,
Experience with drug safety databases and/or document management systems is an advantage.
As a person we expect you to:
Be pro-active, self-driven, well organized and with good oversight,
Have a positive energy, good interpersonal skills, and able to build sustainable business relations,
Have an eye for detail, accuracy, and quality,
Be a team-player as you will be part of a small team, but at the same time fully capable of assuming responsibility for your own tasks,
Work effectively and be flexible in a fast-paced environment with changing priorities,
Be an exact and precise communicator, fluent in English, both written and spoken.