Director, Safety Surveillance Physician
2 months ago
Johnson & Johnson, is recruiting for a **Director, Safety Surveillance Physician (Oncology) **to be located in Titusville, NJ; Raritan, NJ; or Horsham, PA.
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 Credo.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
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.
- Participation in pharmacovigilance matrix-teams (i.e. Safety Management Teams) responsible for pharmacovigilance activities focused on products and therapeutic areas as assigned
- Support GMS Product Teams to drive change, increase efficiency, effectiveness and quality, and foster alignment, across GMS and with key stakeholders
- As co-owners of sections of the Investigators Brochure for their assigned products, the SSP will provide data and assure accurate representation of adverse reactions that are considered as expected.
**Qualifications**:
**Minimum Qualifications**:
- A Physician (MD or equivalent) with a minimum of 2 years of clinical medicine.
- A Board certification (if US) is preferred.
- Medical specialization is preferred.
- A minimum of 4 years of experience in industry, academia or patient care settings is required.
- Oncology and Immunology therapeutic area experience preferred
- Direct experience in pharmacovigilance is strongly preferred.
- Experience and knowledge of Good Clinical Practices is required.
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
- Fluent in written and spoken English.
- Working knowledge of the use of Microsoft suite of software products, including Excel and Word.
- Must be able to work independently with minimum supervision to meet tight deadlines.
The anticipated base pay range for this position is $186,000 to $322,000.
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. Additional information can be found through the link below.
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, na
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