J&J Family of Companies Safety Surveillance Physician (Director) 1 of 2 in Horsham, Pennsylvania
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Safety Surveillance Physician (Director), 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. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
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 Safety Surveillance Physician (Director) 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.
The Director, SSP may also support Vendor Oversight for vendor physicians.
Analysis and assessment of SUSARs
Analysis and assessment of Critical Cases (DME, EVOI, etc.)
Detect single case signals/through validation
Member of Safety Management Team
Actively participate in Signal Evaluation
Ensure Follow-up of Critical cases/ Events of Special Interest (RMPs identified risks, etc)
Investigator Brochure activities
Vendor oversight, including participation in QC activities
Medical Safety Officers – frequent. Discuss findings from ICSR review/AOSE/DME and/or systematic surveillance program and suggest potential safety issues for further evaluation. Provide surveillance consultation on ad hoc safety issues and queries. Participate with Medical Safety Officers on preparation of Pharmacovigilance Plans or Risk Management Plans.
Aggregate Reports Group- occasional. Discuss signal detection findings and suggest potential safety issues for discussion in PBRER and other regulatory reports. Suggest potential search and analysis strategies for case series of interests.
Support Desk – occasional. Suggest potential search strategy to identify case series of interests.
Safety Associates—frequent. Reviews the AE reports prepared by the Safety associates and
amends as needed. Requests specific follow-up information on cases. Ensures that the Safety associates are kept informed of product-specific information, such as labeling changes, new protocols, or potential safety signals.
Pharmacovigilance Physicians (PVP)—frequent. Ensure bi-directional flow of product-specific information via product-specific meetings, ad-hoc emails/telecons etc.
Global Medical Safety Operations Physicians (GMSOP)-frequent. Ensure bi-directional flow of product-specific information via product-specific meetings, ad-hoc emails/telecons etc.
Methods and Analytics – occasional. Ongoing receipt of training for systems, tools and methodologies for aggregate data analysis and signal detection.
SSP Team Lead – frequent. Ongoing discussions of ICSRs, AOSEs, performance and development as well as other work-related issues.
Signal Management Group- frequent. Collaboration regarding potential signals.
Clinical leaders, Study Responsible Physicians, and Global Regulatory Leads – frequent. Notify of SUSARs and Analysis of Similar events (AOSE), discuss company causality assessment, and request submission of queries relevant to the SUSARs.
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.
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 required.
Knowledge of pharmacovigilance regulatory requirements in US, the EU and globally is strongly preferred.
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.
United States-Pennsylvania-Horsham-800/850 Ridgeview Drive
North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC (6084)