Director, Safety Surveillance Physician

Janssen Research & Development, LLC, a member of the J&J family of companies is recruiting for a Director, Drug Safety Surveillance to be located in Horsham, PA or Raritan, NJ! At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process. The Director, Safety Surveillance Physician (Director, SSP) has primary responsibility for determining the medical and scientific relevance of adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area. These responsibilities include spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data. SSPs are responsible for the medical assessment of case level and aggregate safety data for new safety concerns and trends and the communication of these issues to the SSP Team lead. Additionally, SSPs participate in matrix management activities (e.g. Safety Management Team) and provide pharmacovigilance expertise on individual case reports. SSPs support activities such as evaluating safety issues from various sources including Designated Medical Events (DME) and Events of Interest (EVOI), preparation of aggregate safety reports such as PBRERs, ad-hoc regulatory reports, Risk Management Plans, and interpretation of surveillance and product quality data. The Director, SSP has additional responsibility to play a significant role as a senior technical leader of internal and external business initiatives. Principal Responsibilities: o Analysis and assessment of SUSARs o Analysis and assessment of Critical Cases (DME, EVOI, etc.) o Detect single case signals/through validation o Member of Safety Management Team o Actively participate in Signal Evaluation o Ensure Follow-up of all critical case/ Events of Special Interest (RMPs identified risks) o PBRER activities o Investigator Brochure activities Qualifications • A Physician (MD or equivalent), is required. A Board Certification (if US) is preferred. • A minimum of 6 years of experience in industry, academia or patient care settings is required (may include Residency training and Fellowship training). • Direct experience in pharmacovigilance is strongly preferred. • A minimum of 2 years in clinical practice after postgraduate training program is preferred. • Experience and knowledge of Good Clinical Practices is preferred. • Knowledge of pharmacovigilance regulatory requirements in US, the EU and globally is strongly preferred. Sound knowledge of general medicine and clinical practice, and the ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential. Good communication skills (written and verbal) and the ability to work in a team-oriented, matrix environment is necessary. Significant experience and judgment required to identify and evaluate issues likely to be relevant in understanding safety profiles of a large product portfolio. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. 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 United States-Pennsylvania-Horsham-800/850 Ridgeview Drive Other Locations North America-United States-New Jersey-Raritan Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2206045950W