Associate Director of Safety Physician
A global pharmaceutical organisation is recruiting for an Associate Director of Safety Physician to join their team in Germany. If you're looking for a change a pace, join this revolutionary ream and help change the face of medicine.
- Participating in the conduct of pharmacovigilance for assigned products or projects including medical assessments, on-going safety evaluation, signal detection and benefit-risk assessments
- Interacting with EMA, NCAs, Region Europe Affiliates, partners and service providers
- Contributing to and reviewing key Pharmacovigilance documents such as Risk Management Plans, safety sections and other labelling documents.
- Provides expert knowledge to ensure that the documents meet the regulatory requirements.
- Participates in NDA/MAA filings, health authority interactions, and FDA Advisory Committee meetings, as applicable
- Training of company personnel, Contract Research Organisations, and investigational site personnel regarding Pharmacovigilance related issues
Skills and Requirements
- University degree in Medicine (Medical Doctor)
- At least 2 years experience as a safety/PV professional, preferably in a global role
- Experience in interacting with global regulatory authorities
- Strong knowledge of EU Pharmacovigilance legislation, including GVP, and familiar with international regulations such as US FDA regulations,
- Excellent written and oral communication skills in English
- Good understanding of clinical practice in Europe. Experience with patient care in Europe preferred
- Good presentation skills
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.