DescriptionJohnson & Johnson Innovative Medicine is recruiting for a Director, Safety Surveillance Physician Team Lead (SSPTL) located in the UK (High Wycombe, England) or East Coast US (Raritan, NJ; Titusville, NJ or Horsham, PA). Remote work options may be considered on a case-by-case basis, and if approved by the company. This role will report to the Head of the Safety Surveillance Physician Group (HSSPG). The objective of this position is to provide therapeutic area medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process; this includes oversight of signal detection activities at the single case level, single case medical review.The SSPTL has additional responsibilities to those of the Director, SSP in that the TL will lead a group of physicians who are responsible for single case signal detection and the medical evaluation of adverse event data according to international regulation and company SOPs. The SSPTL, is expected to play a greater role as a senior technical leader and when required, to provide guidance to SSPs in evaluating safety issues/signals in collaboration with the Medical Safety Officers. The medical expertise of the Director SSPTL will be reflected in activities such as managing a product area or project team.Direct, supervise and provide leadership to the Safety Surveillance Physicians for JnJ products under GMS responsibility. Assign workflow as appropriate to assure compliance with timelines. Actively participate in talent acquisition as well as provide guidance related to professional development to reports.Duties and responsibilities include, but are not limited to the following:Ensure active participation of SSP as well as oversee quality of output by SSP for the SSP activities which include but are not limited to:Analysis and assessment of SUSARsAnalysis and assessment of Critical Cases (DME, EVOI, etc.) Detect single case signals/through validationMember of Safety Management Team Actively participate in Signal EvaluationEnsure Follow-up of all critical case/ Events of Special Interest (RMPs identified risks)PBRER activities Investigator Brochure activitiesManagement of the business end for SSP contractors Assist the SSG Lead or lead projects and processes of technology and scientific innovations for the Medical Analytics and Safety Surveillance group.Medical assessment for assigned product at case level and aggregate safety data for new safety concerns and trends and the communication of these issues to the SSG Lead and others as applicable.Participate in matrix management activities (e.g. Safety Management Team) and provide pharmacovigilance expertise on individual case reports.Analyze 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.QualificationsMinimum Qualification A Physician (MD or equivalent) with a minimum of 2 years of post-graduate clinical medicineBoard certification (if US) is preferred.Medical specialisation preferred.A minimum of 6 years of experience in industry, academia or patient care settings is requiredDirect experience in pharmacovigilance is required. (Proven track record in dealing with difficult safety issues, clinical safety data, and strong collaborative and networking skills. Ability to work in a global team-oriented, matrix environment)Experience and knowledge of Good Clinical Practices is required.Knowledge of pharmacovigilance regulatory requirements in US, the EU and globally is required.Strong management experience in supervising a group of employees preferred, proven leadership skills required.Experience in developmental, as well as post-marketing, safety assessment is preferred.Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.Fluent in written and spoken English.A working knowledge of the use of Microsoft suite of software products, including Excel and Word is required. Excellent verbal and written communication skills are required.For United States applicants:The anticipated base pay range for this position is $238,000 to $322,000.The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please go to: 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.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .Job Field: Product Safety Risk Management MDOrganization: Janssen Cilag Ltd. (7360)Travel: Yes, 10 % of the Time