Associate Director, Global Medical Safety Operations Physician
Janssen Research & Development, L.L.C., a member of Johnson & Johnson’s Family of Companies Is currently recruiting for an Associate Director, Global Medical Safety Operations Physician located in Horsham, PA, Raritan, NJ, High Wycombe, England or Aschwell, Switzerland.
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 regarding the operational aspects of individual case medical review.
The Associate Director, Global Medical Safety Operations Physician (GMSOP) 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.
Responsibilities:
Medical Review
- Non-Suspected Unexpected Serious Adverse Reaction (SUSAR) clinical trial cases for products in development
- Non-med significant Follow-up SUSARs
- Partner SUSARs (where is Company does not change the Business Partner assessment)
- SUSARs for non-company sponsored trials
-
Spontaneous/ solicited individual case safety reports for products as assigned
- Perform aggregate review of non-serious cases in line listings
- Evaluate Individual Case Safety Report (ICSRs) for potential product quality issues (including device malfunctions, if applicable).
- Watchlist
- Targeted Follow-up Questionnaires
- Investigator Brochure activities as assigned
- Anticipated Events activities as assigned
All other operational activities that require physician input example:
- Standard Operating Procedures (SOPs),
- CAPAs
- Periodic Adverse Drug Experience Reports (PADERs)
Qualifications
- A Physician (MD or equivalent), is required. A Board Certification is required.
- A Minimum of 2+ years of clinical practice experience after postgraduate training program is preferred
- A minimum of 3 years of experience in industry, academia or patient care settings is required.
- Experience in industry is preferred.
- Direct experience in pharmacovigilance is 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 required.
- Experience and knowledge of Good Clinical Practices is required.
- Knowledge of pharmacovigilance regulatory requirements in US, the EU and globally is preferred.
- Good communication skills (written and verbal) and the ability to work in a team-oriented, matrix environment is required.
- Significant experience and judgment required to identify and evaluate issues likely to be relevant in understanding safety profiles of a large product portfolio is required.
- Up to 10% domestic and/or international travel is required.
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, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
2105928898W