PHARMACEUTICAL PHYSICIAN / SAFETY PHYSICIAN - Netherlands
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- We are focusing on the development of new and innovative medicine that have a major impact on people's lives.
- We perform clinical trials in therapeutic areas such as cardiology, diabetes, CNS and infectious deseases.
- At this moment we have an interesting opportunity for a Pharmaceutical Physician (BIG registered).
- Our new Pharmaceutical Physician will manage and provide all medical and safety aspects of our clinical trials, will also be involved in protocol reviewing and provide scientific input.
- You will work in a close-knit team of responsible colleagues.
- It is a diverse job in an organisation with short lines, with excellent opportunities to put your ideas for improvement into practice.
- The Pharmaceutical Physician reports to the Director Medical Affairs of our Medical and Safety team.
Tasks and responsibilities
- Provides medical and safety input into proposals, bid defenses and protocols;
- Coordinates, supports and provides medical and safety input and activities to internal and external clients during all phases of the project, including periodic status reporting of the designated project(s);
- Ensures, in collaboration with Safety Officers, safety reports and documents are in place and handled according to set timelines and quality of designated projects;
- Ensures all necessary procedures, systems, tracking tools and documents are in place;
- Represents the department during in- and external meetings;
- Collaborates effectively in (project) teams;
Individual patient care:
- Adjudicates, advances and safeguards the health of individual subjects by medical review medical monitoring (including but not limited to: adverse events, medication, diagnostics) and signal management (early signals will be detected to ensure safety of subjects);
- Advises and informs investigators and sponsor on medical issues;
- Advises and informs ethical committees and regulatory authorities on medical issues;
- Advises investigators and sponsor on eligibiliy (compliance to all inclusion and exclusion criteria);
- Participates in steering committee and data review meetings as safety expert;
- Responsible for the process of safety reporting of the individual subjects participating in clinical trials within applicable regulations and according to EU Directive, guidelines;
- Advises on continuation of trial drug- if applicable.
Desired skills & experience
- Medical Doctor with Dutch BIG registration;
- A minimum of 2 years experience in the pharmaceutical and/or CRO industry or equivalent clinical research experience;
- Preferable familiar with Pharmacovigilance / safety databases such as PV 24/7;
- Excellent (English) oral and written communication skills;
- Analytical, decisive, flexible, result driven, proactive;
- Ability to balance medical competence with industry standards to achieve business goals.