Drug Safety Physician – Germany

Reference No: J6069

Drug Safety Physician Job– Western Germany

Job Description:

•Management of safety information, from various sources including:
- clinical trial Serious Adverse Events
- spontaneous reports of Adverse Drug Reactions
- local and global literature cases
•Support of clinical safety data generation, signal detection, assessment and reporting within clinical development programs and for commercial products
•Establish and maintain structures within the PV system to support the drug development and commercialization phase
•Development and maintenance of a safety surveillance strategy for the assigned products
•Ongoing pro-active signal detection and evaluation, and preparation of drug safety reports including presentation to Drug Safety committee, as necessary
•Contribute medical assessments to periodic safety reports (PSURs and ASRs)
•Contribution to preparation of Risk Management Plan
•Respond to queries relevant to safety from health authorities, affiliates and other internal or external sources
•Contribute to safety sections of Investigator’s Brochure, Clinical Study Protocols and the development of core Safety Information
•Respond to queries relevant to safety from the affiliates and other internal functions

Candidate Requirements:

•MD with hands-on expertise in safety processes and regulations
•Industry experience with handling safety processes and restrictions in clinical development, preferably in infectious disease indications and/or oncology
•Solid scientific background
•Team orientation and intercultural competence, organisation awareness, analytical mindset
•Fluent German language skills and a good command of scientific and business English

If this role is of interest please email spencer@onlymedics.com

Key Words:

Pharmaceutical, biotechnology, medical, medic, physician, MD, PSUR, safety, pharmacovigilance, manager, leader, drug safety, expert, Switzerland, Europe, Germany, global, periodic.

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