Remote Medical Reviewer
Proclinical is currently recruiting for a remote Medical Reviewer for a pharmaceutical company located in Princeton, NJ. Successful candidate will be responsible for guiding, implementing and executing the processes that support medical content of clinical trial and/or post-marketing adverse event reports.
- Serve as a point of contact between Drug Safety Operations and the Safety Evaluation and Risk Evaluation (SERM) team regarding medical content and regulatory reporting for program-specific ICSRs.
- Communicate with SERM Program and Risk Leads regarding cases of special interest or SUSAR reports from clinical trials and provide medical insights on case information.
- Provide medical review expertise and guidance on interdepartmental and/or cross-functional initiatives including, process improvement standards development, SOP/MAN creation, and metrics with regards to medical review and case processing.
- Support the development and review of expected term lists to facilitate expectedness assessments
- Perform individual safety case medical assessments of causality, expectedness and seriousness of reported clinical trial and post-marketing safety reports in alignment with corporate SOPs
- Contribute to the resolution of issues from cases of high complexity through medical expertise and team interactions
- Ensure the medical accuracy of the narrative and medical coding within each safety report and provide sponsor comment on individual safety reports where required
- Conduct evaluation of other relevant safety information (e.g. from non-clinical studies and product quality complaints) as required
- Serve as point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
Skills and Requirements:
- MD preferred.
- Relevant pharmaceutical industry experience/expertise, with significant previous experience in pharmacovigilance in a medical or operational position.
- Ability to establish effective working relationships with people in a wide variety of disciplines and backgrounds; manage and prioritize multiple projects and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure.
- Demonstrated knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments.
- Proven ability to strategically apply principles of clinical assessment of adverse events in the pharmaceutical industry.
- Robust knowledge of MedDRA dictionary with relevance to adverse event coding.
- Strong clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
- Experience leading teams and managing staff.
- Strong analytical, assessment and problem-solving skills.
- Demonstrated ability to read, analyze and interpret clinical data and information.
- Excellent interpersonal skills and professionalism.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.