Job Description - PV Risk Minimization Physician (170008ZJ)
PV Risk Minimization Physician(
Nestlé Skin Health’s is a global leader focused on enhancing the quality of life by delivering science-based solutions for the health of skin, hair and nails. As one of the category’s leading companies, Nestlé Skin Health conducts groundbreaking product research to provide both the healthcare community and the consumer with an ongoing progression of innovative technologies and products to protect, serve and enhance skin health. Nestlé Skin Health is a wholly owned subsidiary of Nestlé.
For our Global Quality and Pharmacovigilance Organization based in Lausanne, Switzerland, we are currently looking for a:
Pharmacovigilance / Drug Safety Risk Minimization Physician
In this challenging and dynamic role, you will be part of the Global Quality and Pharmacovigilance Organization and report to the Head of Pharmacovigilance Risk Management.
The core mission of the Global Quality department is as follows:
Within his department, the Pharmacovigilance / Drug Safety Risk Minimization Physician specific mission is to:
- Protect NSH customers from safety issues (from Innovation to Solution);
- Promote safe and effective use of NSH products;
- Lead the scientific and operational activities - across NSH - relating to the detection, assessment, understanding and prevention of adverse effects;
- Ensure customers satisfaction as well as regulatory compliance in all markets;
- 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 Nestlé Skin Health’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 re-ports, medical review of ICSR as needed;
- Be responsible of the scientific review of safety related information in study protocols, study reports, Investigator Brochure, CCDS, CSI, product labelling, DSUR/PSUR/PBRER as well as in responses to specific questions from Health Authorities;
Further duties & responsibilities include:
- Propose measures aiming at minimizing risks during clinical development; re-lease/update the Development Risk Management Plans (DRMPs);
- For assigned compounds, interact with internal and external stakeholders to ensure monitoring of safety profile, signal validation & signal evaluation, and propose appro-priate risk management and risk minimization measures;
- Review/provide input to Aggregate Reports (e.g. DSUR, PSUR, PBRER);
- Review/provide input to Risk Management Plans (RMP);
- Contribute to answers to safety-related questions from Regulatory agencies and inter-nal/external stakeholders;
- Contribute to Investigators/KOLs meetings for safety-related aspects/questions;
- Contribute to Due Diligences, as needed;
- Ensure on-going safety data review during clinical trials through Safety Plans and Safety Review Meetings;
- Escalate and present safety issues at company governance bodies;
- Medical review of ICSR as needed;
- Ensure effective collaboration with the Strategy & Innovation Group, Clinical Develop-ment group, and the other stakeholders;
- Contribute to process optimisation initiatives and -where needed- set up new activi-ties;
- Provide guidance and medical support to the safety scientists, without direct reporting line.
Requested Education & Experience:
- Medical doctor;
- Additional degree in clinical pharmacology and/or pharmacovigilance/drug safety and/or public health and/or epidemiology;
- At least 6 to 8 years of pharmacovigilance experience in pharmaceutical/medical de-vice companies at an international level;
- Significant experience and knowledge of international clinical development and post marketing regulations applicable to drugs; knowledge of PV regulations for medical devices is an extra;
- Interactions with Health Authorities in the US, EU and other geographies to address safety medical questions;
- Sound knowledge of the global pharmacovigilance and safety requirements for non-clinical and clinical development, registration process and post-marketing;
- Experience in analyzing and managing significant safety issues across product life cycle;
- Be able to identify risks and propose mitigation actions in complex and critical situa-tions and the ability to a multifunctional team and achieve deliverables within agreed timelines.
- High ethical standards, being a role model of business compliance and integrity is required;
- Ability to work independently, to take responsibility for own projects/tasks, and to provide key input to difficult or sensitive projects;
- Results orientated with a hands-on, can-do attitude;
- Positivity, flexibility and adaptability with agile thinking;
- Ability to manage stress and dynamic environmental changes and to adapt in a fast changing business environment;
- Ability to manage ambiguity and “conditional” problem solving;
More details on behavioral, functional and technical competencies will be provided upon application.
- English fluent written and oral, other spoken languages are an asset in building connections both internally as externally;
- eDocument Management, PV computerized systems.
Job Posting:Jul 17, 2019, 3:15:09 PM