Johnson & Johnson Careers
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Safety Surveillance Physician
Requisition ID: 1805635097W
The objective of this position is to implement surveillance strategies in proactive and systematic detection and evaluation of new safety signals and emerging safety signal trends. These activities include the evaluation and interpretation of case and aggregate safety data from sources such as medical literature, safety databases and clinical studies. This position, in partnership with OCMS Medical Safety Officers, as member of Surveillance Teams, Safety Vigilance and Safety Sciences also assist in developing product specific hazard evaluations, risk assessments, pharmacovigilance and risk management plans.
The Safety Surveillance Physician will function at a high level of independence and must be proficient in providing verbal reports, presenting data and preparing written reports, medical reviews and regulatory safety documents.
The surveillance physician will perform tasks hands-on both as individual contributor and provide oversight to other team members including those under the external service providers.
Development and implementation of product surveillance strategies in proactive and systematic detection and evaluation of new safety signals and emerging safety signal trends including but not limited to, the following :
- Identify and evaluate new safety signals and trends by conducting systematic reviews of case and aggregate data with a focus on spontaneous adverse event reports from safety databases. Prepare topic reviews and summary analysis reports of safety data. Provide recommendations for further evaluation and or risk mitigation
- Review, analyze, interpret and summarize case and aggregate safety data from clinical, post-marketing and observational studies, medical literature, and product quality databases. Provide safety conclusions and recommendations for appropriate course of act
- Assist in addressing product specific safety issues as member of surveillance teams
- Assist OCMS Medical Safety Officers in developing and implementing product specific medical safety assessments, pharmacovigilance and risk mitigation plans
- Provide vendor oversight including mentoring of other safety surveillance physicians and other health care professionals under the external service providers
- Board-certified physician with 2 years of clinical practice / safety / clinical data analysis experience (or equivalent) is required. Experience in pharmaceutical medicine is preferred. Demonstrated knowledge of regulatory requirements for global pharmacovigilance is preferred.
- Ability to analyze, interpret, synthesize and present complex data in a clear and concise scientific mannfer
- Excellent verbal and written communication skills, including formal presentation skills
- Working knowledge of the use of Microsoft Office
- Excellent attention to detail
- Diligence in record-keeping and records organization
- Able to meet deadlines and handle multiple priorities
- Strong collaborative and interpersonal skills; results-oriented and able to independently create and deliver
Johnson & Johnson International (Singapore) Pte. Ltd. - ROHQ
Drug & Product Safety Science