Associate Director of Safety Physician job in Frankfurt am Main, Germany

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: PV Physician

Location: Germany

This vacancy has now expired. Please see similar roles below...

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.

Job Responsibilities

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

To Apply

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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.