Proclinical is currently recruiting for a REMOTE Medical Reviewer with a biotechnology company located in Philadelphia, PA.
- Completes assessment and medical review of post-marketing and/or clinical trial adverse event reports within regulatory and departmental timelines
- Ensures adequacy of recording, summarization, and handling of adverse events for marketed and developmental products.
- Assesses seriousness and expectedness for reported adverse events and company causality for relevant adverse events.
- Ensures accurate coding of adverse events and serving as a resource to the medical coding staff and due diligence in characterizing adverse events.
- Authors analyses of similar events for select serious adverse reactions.
- Monitors global case review activities to ensure adequate timeliness of medical review.
- Liaises with program & product physicians to ensure consistency in approach to medical review as well as ensure focused oversight on critical areas related to ongoing safety analyses.
- Conduct oversight activities of global case medical review quality.
- Provides consultation for medically related questions from participating vendors, affiliates, etc.
- Participate in inspection readiness activities and regulatory inspections.
- Provides training on medical topics to the global case management team.
- Compliance with corporate and department SOPs and conventions while maintaining a working knowledge of global safety guidelines and regulations.
- Safety monitoring of marketed or investigational products and adherence to safety regulations worldwide.
- Assessment of Risk/Benefit relationship is crucial to any product's success.
- Adherence to pre-determined timelines has a direct impact on regulatory Compliance.
- Train and mentor new/junior physicians and safety associates.
- Serve as a resource to others in the department for medical questions.
Skills and Requirements:
- Minimum educational level necessary to perform the job (High School diploma, Assoc Degree, Bachelor's Degree, Masters, PhD).
- Minimum of 3 years' experience in a drug safety surveillance setting within the pharmaceutical/biopharmaceutical industry or in a clinical setting.
- Demonstrate strong ability to prioritize.
- Demonstrate a high level of global understanding of GSRS processes from Initial Data Intake to Distribution.
- Solid understanding of worldwide post-marketing and clinical trial adverse event regulations.
- Strong ability to understand and evaluate technical, scientific and medical information.
- Initiate collaboration with staff members to create an effective team environment.
- Demonstrate excellent communication skills.
- Good computer skills and ability to learn new systems as they are implemented.
- Ability to interact effectively with global staff of multiple disciplines within the company.
- Working knowledge of cGCP and GVP regulations, 21CFR Part 11, MedDRA and HIPAA.
If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.
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.