Country Safety Team Lead, Switzerland - 2406160929W

　　Description

　　The Johnson & Johnson Family of Companies

　　A global leader in health and personal care, with over 125,000 employees in over 275 companies in 60 countries. We work with partners in healthcare to touch the lives of more than a billion people every day throughout the world.

　　“By caring, one person at a time, we aspire to help billions of people live longer, healthier, happier lives.”

　　We have a new and exciting opportunity to hire a Country Safety Team Lead for our Pharmacovigilance team based in Zug, Switzerland.

　　Key Responsibilities :

　　Ensuring that the LOC Safety activities, related to medicinal products are managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and following any Pharmacovigilance agreements with third-party business partners

　　Having appropriate Pharamacovigilance and Risk management systems in place to assure appropriate oversight for products within its responsibility

　　Managing and coaching Local Medical Safety Team (LMS)

　　Core Job Responsibilities:

　　The Country Safety Lead will

　　Ensure that day-to-day PV requirements are met and ensure regulatory compliance is maintained at the LOC level.

　　Oversee data-generating activities to ensure appropriate review and reporting processes are included in project documents for reporting potential AEs (e.g. patient support programs, market research surveys, internet sites),

　　Ensure awareness of changes in regulations which may have an impact on pharmacovigilance activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups

　　Ensure adequate local signal detection process if required and ensure reporting of potential single case signals or clusters of similar events seen in case processing

　　Provide local medical safety insights to the local business to support the safe use of our products

　　Risk Management:

　　Have an appropriate system of Risk Management in place in order to assure appropriate oversight for products within its responsibility

　　Collaborate with the Medical Affairs and Regulatory Affairs team to ensure that RMP activities are completed in a timely manner

　　Ensure implementation and tracking of RMP activities are in place including documentation of completed activities

　　Review all risk management plans and PSURs to obtain information on the risk/benefit profile of products

　　Qualifications

　　Education, Experience , and Skills:

　　5 years of experience in PV/medical-related field essential; experience working in the pharmaceutical industry is strongly preferred, as is line management experience

　　Excellent Knowledge of PV regulations

　　Excellent written and spoken communication and presentation skills

　　Effective decision maker with the ability to assess the impact of actions taken locally on the global PV system

　　Fluency in written and oral English as well as German.

　　Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity

　　Strong influencing skills with the ability to explain and defend a position which is in the best interests of patient safety

　　We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other employment benefits and privileges. Please contact us to request accommodation.

　　Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

　　Primary Location Europe/Middle East/Africa-Switzerland-Zug-Zug

　　Organization Janssen Cilag Ltd. (7360)

　　Job Function Pharmacovigilance

　　Req ID: 2406160929W