Drug Safetly Physician/Consultant
- Spring, PA
1525 Morris Ave.
UNION, NJ 07083
We currently have a contractor position for a Safety Physician. The term of the assignment is approximately 3-6 months and will be based out of Springhouse PA. The bill rate is open at this time and will be determined based on the candidates we receive.
The required scope of work, skill set/experience includes the following:
This contractor position is for a Global Medical Safety (GMS) Physician who will help ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products within the Immunology TA. The GMS Physician will help ensure communication of potential and known risks, when appropriate, to the TA Safety Head, Chief Safety Officer (CSO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the GMS physician will also contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of J&J pharmaceutical products.
- Provide medical expertise to the GMS TA and provide medical oversight to non-physician GMS staff
- Provide end-to-end (Phase 1 through product life cycle) safety support and surveillance
- Chair a multidisciplinary Safety Management Teams (SMT) for assigned products whose responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)), as well as other activities related to managing the safety profile of assigned products.
- Participate on TA Clinical Development Teams (CDTs) and Clinical Teams (CTs) as deemed necessary by the TA Safety Head
- Present medical safety and risk management evaluations as necessary to the CSO, the GMS Senior Leadership Team, and the Global Safety Council (GSC)
- Participate in HA interactions regarding safety and risk management, both written and verbal
- Provide input and review to key regulatory or clinical documents as appropriate, to ensure these key safety documents are of high medical and scientific quality.
Education and Experience:
- Physician, with 4-5 years related experience, with Board Certification (if US)
- Demonstrated skills in clinical medicine and/or Pharmacovigilance
- Demonstrated in-depth knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations
- Ability to influence, negotiate and communicate with both internal and external customers
Required Technical Knowledge and Skills:
- Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications.
- Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans
- Able to plan work to meet deadlines and effectively handle multiple priorities
- Fluent in written and spoken English
- Working knowledge of the use of Microsoft suite of software products including Excel and Word. Proficiency in PowerPoint is desired
- Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable
If you are interested, please e-mail me your resume in word document so that we can discuss further details and submit you to the client immediately. Also, please provide the following information:
Desired Hourly Rate:
Reason for leaving current or last position:
Explain any Gaps in your resume if any:
If you are not interested, but know someone else who might be interested in this position please forward this resume to your friend.
Patel Consultants has been in Business since 1973. To get more information on Patel Consultants please view our website at http://www.patelcorp.com.
SR Technical Recruiter
1525 Morris Avenue
Union, NJ 07083