over 1 year ago
Drug Safety/PV Physician
We are currently working with a leading pharmaceutical company based in Switzerland, with revenue generating around €2bn, who focus on developing treatments and products for dermatology, looking to combat and make a difference to people lives globally.
They currently have a unique opening within the Drug Safety team, to join as a PV Physician on a contract basis and reporting to the Head of PV Risk Management, tasked with ensuring that the products are fit for purpose and safe for consumer use. They would be tasked with being responsible for scientific review of the safety information, minimize the risk within clinical development and create and develop the Risk Management Plans (RMP) for the products during development.
Further responsibilities include:
- 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.
- 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 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.
- 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
If this is something of interest to you, and you are keen to hear more, please reach out to one of the consultants within the Life Science team and click the Apply Now button!