Berlin, Germany; Mainz, Germany; Martinsried, Germany | full time | Job ID:8594
The Medical Safety Physician is assigned to one or more study management team(s) in the oncology therapeutic area and together with the assigned Safety Scientist(s) provides Medical Safety Support to the team. Direct responsibilities of the Safety Physician include input to clinical trial protocols, study site (investigator) training, safety data assessments including adverse events of special interest, assessment of individual serious adverse events, determining follow-up information needed, safety signal detection and evaluation activities, and oversight of compliance with GCP and reporting regulations. The Safety Physician contributes to the periodic safety reports (DSUR), relevant updates of reference safety information, the Investigator’s Brochure, and Clinical Trial Report.
Main Responsibilities:
* Accountable for the quality performance of one or more safety management team(s) (SMTs)
* Oversees safety monitoring, signal management, and the benefit-risk of assigned products through the product life cycle
* Identifies and leads escalation, management, and communication of safety inquiries and concerns for assigned products
* Formulates and drives the optimal safety strategy for assigned oncology programs in clinical development at the portfolio level
* Presents and interacts with Regulatory Authorities on safety matters
* Oversees quality content of the safety contributions to clinical and regulatory documents
* Represents MSPv in Alliance management projects
* Serves as safety subject matter expert at the portfolio level
* Ensures activities are performed in compliance with applicable law, global and local regulations, and internal and external quality standards
* Trains and mentors Safety Physicians and Safety Scientists
What You Have to Offer:
* Medical Degree (or internationally recognized equivalent); MD/PhD and/or certified training in a relevant medical discipline is a plus.
* Extensive drug safety/pharmacovigilance experience within the biopharmaceutical/biotechnology industry
* Exposure to, or direct experience in working with Regulatory Agencies on development strategies for innovative oncology products
* Has achieved demonstrable results in a matrix organization and in a multidisciplinary team
Apply now - We look forward to your application!
Apply to our Berlin, Germany; Mainz, Germany; Martinsried, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).
Job ID 8594 (please always specify if you have any questions)
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