Medical Review Physician
We are currently searching for a skilled professional to join a well-known client’s team as a Medical Review Physician, in Princeton, New Jersey. The Medical Review Physician evaluates cases for seriousness, relatedness, and expectedness according to the protocol, investigator brochure, and/or package insert, confirms presence of adequate information needed to perform case evaluation, reviews relevant source documents for consistency and verification of adverse event data and review narratives in Argus and CSR narratives.
- Perform assessment of ICSR cases
- Primary reviewer of serious adverse events, including SUSARs, for clinical and post marketed products
- Unblinding of clinical cases (if required) during medical review
- Preparation & creation of analysis of similar events (if needed)
- Assesses clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communication is required
- 5 +years pharmaceutical experience preferably performing Medical Reviews
- Ability to critically evaluate safety data from multiple sources (clinical trials, literature, etc.)
- Demonstrated qualities of competency, accountability, initiative, and leadership
- Experience in process improvement initiatives
- Extensive knowledge of US, ICH and EU PV and GCP regulations
- Excellent strategic decision-making and analytical skills
- Computer skills including proficiency in use of Microsoft Word, Excel & PowerPoint
- Strong leadership skills with excellent track record
- Strong verbal, writing and organizational skills, including good command of English
- Experience with Regulatory Authority Inspections (PV and GCP)
- Experience working with vendors
- A physician (MD or equivalent)
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.