Beschreibung
Pharmacovigilance Risk Minimization Physician (m/f/d)
Reference: -en
Start: asap
Duration: 4 MM++
Main tasks:
- In this challenging and dynamic role, you will be part of the Global Quality & PV department and report to the Head PV risk Management. Within department, the Global PV Risk Minimization Physician specific mission is to:
- Ensure that the benefit risk assessment is current for a specific set or category of NSH products and that any change is handled as per NSH’s decision-making principles.
- Be accountable, in a matrix organization, for the Benefit and Risk activities including signal detection, risk management, mitigation plans, safety analyses in aggregate reports, medical review of ICSR as needed.
- Be responsible of the scientific review of safety related information in CCDS, CSI, product labelling, investigator brochures, DSUR/PSUR/PBRER as well as in responses to specific questions from Health Authorities.
- Propose measures aiming at minimizing risks during clinical development; release/update the Development Risk Management Plans (DRMPs).
- Organize regular (i.e. at predefined milestones) Product Safety Team (PST) and Portfolio Safety Committee (PSC) meetings for products.
- Review/provide input to Development Safety Update Reports (DSURs) and Aggregate Reports (PSUR, PBRER).
- Review/provide input to Risk Management Plans (RMP).
- Review/provide input to Common Technical Document (CTD) or equivalent document for Dossier Registration and label.
- Contribute to answers to safety-related questions from Regulatory agencies
- Contribute to Investigators/KOLs meetings for safety-related aspects/questions.
- Ensure on-going safety data review during clinical trials through Safety Plans and Safety Review Meetings.
- Validate safety signals based on the review of single cases and aggregate data, and escalate as appropriate during ad-hoc safety PST and PSC meetings.
- Ensure effective collaboration with the Strategy & Innovation Group, Clinical Development group, and the other stakeholders.
Main qualifications
- Medical doctor and an additional degree in clinical pharmacology and/or pharmacovigilance and drug safety.
- Experience in interactions with Health Authorities in the US, EU and other geographies to address safety medical questions.
- Good knowledge of relevant regulations and relevant concepts in data management and systems, epidemiology and statistics.
- Ability to identify risks and propose mitigation actions in complex and critical situations and the ability to a multifunctional team and achieve deliverables within agreed timelines.
- English fluent written and oral.
- Act with minimum oversight in most circumstances as well as provide key input to difficult or sensitive projects.
- Excellent interpersonal, collaboration, and negotiation skills; refined communication skills
- High ethical standards, being a role model of business compliance and integrity is required.
- Ability to move and adapt in a fast changing business environment.
Main advantages:
- A highly motivated team and an open way of communication
- A very renowned company
- A city with a high quality of life that perfectly embraces both modern and traditional values
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Nataliia Luchyn
Referencenumber:
Make contact:
Phone:
Email: