Drug Safety Lead
hace 3 semanas
Job Summary
We are seeking a skilled Drug Safety Lead to join our team at Organon.
About the Role
The successful candidate will be responsible for leading signal detection, safety evaluation, and risk management planning for low to medium complexity medicinal products and/or medical devices during clinical development and/or for established brands from a scientific perspective.
Key Responsibilities
- Lead signal detection, safety evaluation, and risk management planning and activities for low-medium complex, medicinal products and/or medical devices during clinical development and/or for established brands from a scientific perspective.
- Develop and implement Drug Safety strategies, risk management plans, and drug safety systems and procedures.
- Ensure that patient risk reduction strategies are included in relevant documents such as clinical study protocols, study reports, informed consent forms, and SmPC/Patient Leaflet.
- Responsible for the review/preparation of individual safety reports (incl. SUSARs) and reports of aggregated clinical data (Annual Safety Reports/Developmental Safety Update Reports) according to legally required timelines to Health Authorities, Ethical Committees, and external Safety Review Boards.
- Oversee programs and registries safety related compliance, including the monitoring and follow-up of reports in special programs such as pregnancy registries, patient support programs, market research, pre-license access programs, digital health solutions if appropriate.
- MedDRA updates for assigned products twice per year.
- Creation and/or maintenance of targeted questionnaires for assigned products.
Requirements
- 3-5 years of PV experience in the pharmaceutical industry.
- Expert knowledge in pharmacovigilance and methodologies in a global environment.
- Sound knowledge of the therapeutic area of assigned products.
- Sound knowledge and/or experience in other related disciplines is a plus, e.g., Pharmacoepidemiology, Pharmaceutical Medicine, Clinical Research, and/or experience in Clinical Pharmacology.
- Experience in Medical Device product quality regulations and safety monitoring is a plus.
Education/Certificates
- MD-degree with several years of clinical experience exercising medical judgment as a physician ideally specialist in Woman's Health, Internal medicine, or Pharmaceutical Medicine. Post-graduate qualifications in other areas are a plus.
- MD/PhD/MSc Equivalent with experience in International Drug Safety, ideally operational, post-marketing as well as clinical drug safety.
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