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Global Pharmacovigilance Specialist
- Permanent
- Pharmacovigilance
- Germany
This vacancy has now expired. Please see similar roles below...
Proclinical are recruiting for a Global Pharmacovigilance Specialist to join a pharmaceutical organisation. This role is on a permanent basis and is located in Germany.
Responsibilities:
- You will prepare "health hazard evaluations" in the case of drug risks due to product quality defects.
- Serve as a representative for the division as well as contribute to preparing and following up on GxP audits and inspections.
- Responsible for risk management and the development of risk management plans.
- Accountable for the Medical/pharmacological review of individual case reports/adverse event reports from the international spontaneous reporting system and clinical trials.
- Preparation of periodic safety reports (e.g., DSUR, PSUR).
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in pharmacy.
- Demonstrable experience within a research-based pharmaceutical organisation or CRO.
- Familiarity working in safety databased and medical coding such as MedDRA.
- Expertise in both German and European pharmaceutical legislation and of pertinent ICH and FDA regulations.
- Excellent knowledge of German and European pharmaceutical legislation as well as good knowledge of pertinent ICH and FDA regulations.
- Fluency in the English language.
- Communication skills both verbally and in writing.
If you are having difficulty in applying or if you have any questions, please contact Marius Busch at +49 69 5060 7608.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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