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Director, Safety Surveillance Physician (Hematology & Cellular Therapy) - Raritan New Jersey
Company: Disability Solutions
Location: Raritan, New Jersey
Posted On: 04/21/2024
Johnson & Johnson, is recruiting for a Director, Safety Surveillance Physician (Oncology: Hematology & Cellular Therapy) to be located in Titusville, NJ; Raritan, NJ; Horsham, PA or High Wycombe, UK. At Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Johnson & Johnson discovers and develops innovative medical solutions to address important unmet medical needs in the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension. Please visit for more information. We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our . 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; this includes single case signal detection activities for selected products. The Director, Safety Surveillance Physician (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. Additionally, SSPs participate in matrix management activities (e.g. Safety Management Team (SMT)) 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. - Active participation in SSP activities which include, but are not limited to:
- Analysis and assessment of SUSARs
- Analysis and assessment of Critical Cases
- Detection of single case signals/ through validation
- Member of Safety Management Team
- Active participation in Signal Evaluation
- Ensuring Follow-up of all critical case/ Events of Special Interest (RMPs identified risks)
- PBRER activities
- Investigator Brochure activities
- Watchlist activities
- Analysis of Designated Medical Events (DMEs), Events of Interest (EVOIs), and similar critical cases
- Review DMEs and EVOIs and determine potential signals, including DME and EVOI assessments coming from vendors
- Perform validation of potential signals and coordinate with MSO
- Provide recommendations for further evaluation.
- Identification and analysis of new safety signals and trends by conducting systematic reviews of aggregate data
- Perform signal detection activities for selected products (SMART daily alerts).
- Perform validation for signals identified in reviews.
- Prepare summary analysis of safety data for the SMTs. Provide recommendations for further evaluation.
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