Are you someone who likes to keep safety for medicines? Then we are looking for you
You are responsible and accountable for the coordination and medical-scientific monitoring and assessment of the safety profile of one or more specific products assigned to the Global TA.
As this position may require more hands on oversight from the Group Lead or (Medical) Director, assigned products may include high priority marketed products, including those which are marketed in multiple regions, and those with multiple license partners; typical, straightforward global development products.
You leads GPV Product Responsible Teams for assigned products, you are co-chairs Global Development Safety Management Teams and you participates in Global Development Core Teams and Global.
Beside you are responsible and accountable for:
- The timely identification and communication of emerging safety issues and safety updates of the Company Core Data Sheet, Investigator’s Brochure and local product labeling. This also includes responsibility for effective and regular communication with the Global TA Group Lead and with the applicable QPPV;
- The design of safety surveillance strategies, management of safety signals for drug products, both those in development and marketed products, for the collection and identification of safety signals using safety data for signal surveillance activities, categorization and prioritization of safety signals and for authoring, medical review and, as appropriate, approval of safety evaluation reports (SERs), working closely with Global Safety Science;
- The risk management of assigned drug products, both those in development and marketed products, the development and submission of the Risk Management Plan (RMP) and for the execution of risk management strategies in collaboration with internal and external stakeholders, you are working closely with Global Safety Science;
- Timely and high quality contribution to periodic and ad hoc (e.g. Health authority requests) safety reports for assigned products in terms of authoring and review of medical sections, the overall medical-scientific analyses and conclusions;
- The ongoing monitoring and assessment of the safety profile of assigned developmental and marketed products as a member of study teams and for representing GPV in the design, conduct, analysis and reporting of Phase 1 – Phase 3 clinical trials and Post-Authorisation Studies.
The function is home based. You go to the office for a few days every month for team building and training.
To qualify for this position:
- You have a Bachelor's degree in a scientific, health-related field; advanced professional degree such as M.D., D.O., PharmD or PhD preferred;
- You have a minimum of at least 4 years of experience with MD, DO, PhD, or PharmD degree, and at least 6 years of experience with bachelor's or master's degree, in the pharmaceutical industry and / or a relevant health science setting (such as academia): Additional regulatory and / or clinical development experience is a plus;
- You have In-depth understanding of safety regulations for both marketed and investigational products and you have general knowledge of regional and global authority requirements, including ICH, and other applicable requirements, You are able to influence decisions relating to patient safety and assessment of benefit-risk;
- You have Demonstrated leadership responsibilities, including the ability to work within a matrix environment;
- You have sound medical scientific knowledge to evaluate and interpret clinical and scientific data and to communicate with both internal and external stakeholders;
- You have Specific working knowledge and experience in medical safety functions, including risk, signal management and periodic reports;
- You have excellent communication and presentation skills in English (both written and spoken);
- You have strong interpersonal skills with a demonstrated ability to handle conflict situations, think strategically, generate solutions to problems, build consensus across the Global TA and GMS, and understand differences in both regulations and cultures;
- You are ability to deliver under pressure with limited resources;
- You are ability to travel.
The company is one of the top 20 pharmaceutical companies in the world. As a young and forward-thinking company, she is dedicated to improving the lives of people around the world through the introduction of innovative and reliable pharmaceutical products.