Job objective::
Evaluation and registration of reports on potential drug risks
Medical-scientific evaluation of the potential risks of medicines with continuous simultaneous updating of the benefit-risk assessment
Responsibilities:
- Obtaining additional information on the risks of medicines in spontaneous reports and reports to authorities
- Sending reports to the responsible authorities in accordance with the applicable provisions
- Participating in the establishment, maintenance and monitoring of the pharmacovigilance system
- Elaboration of proposals for the necessary measures for drug safety and coordination of these measures with the responsible bodies
- Collection, control of accuracy and documentation of drug safety reports (adverse reactions, pharmaceutical technical defects) in centralized databases
- Study scientific literature and relevant databases with respect to suspected undesirable drug effects
- Participation in the establishment, maintenance and supervision of the pharmacovigilance system of BBMAG
- Regular travel to B. Braun Germany (1- 2 / year)
Your profile:
- University degree in Pharmacy or Medicine
- Postgraduate studies will be an advantage
- 1-2 years professional experience in the field of pharmacovigilance / specialty in clinical pharmacology / monitoring clinical trials
- Fluency in English (written and verbal)
- Proficient in MS Office
- Knowledge of pharmacovigilance database systems is advantageous
- Good organisational skills, attention to detail, high level of personal responsibility and commitment, capable of fast learning and adopting new systems
- Excellent communication and teamwork skills, flexibility and resilience
- Willing to travel internationally.
Benefits:
- Fixed-term contract for 2 years;
- Annual performance bonus;
- Work from home most of the time (80%) – Office work takes place in Sânandrei, Timis County;
- Meal tickets;
- Health subscription (free or discounted medical services);
- 7 Card subscription;
- A premium for family events, according to the Collective Labor Agreement;
- Partial settlement costs for the purchase of eyeglasses;
- Free coffee and dynamic work atmosphere.
B. Braun Shared Services Romania | Adriana Nai |