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location: Cambridge, Massachusetts
job type: Contract
salary: $119.34 - 140.40 per hour
work hours: 9 to 5
The Associate Director, Medical Evaluation is responsible for the medical content and assessment of post-marketing and/or clinical trial adverse event reports, and serving as a medical resource for the GSRS GCM, AR & SS team, GSRS department, and other cross-functional teams as needed. This position ensures that consistent, timely, and focused medical review for safety cases is conducted according to regulatory and departmental timelines at the individual level, and facilitates timely discussion and communication of information related to safety signal evaluation.
- Completes assessment and medical review of post-marketing and/or clinical trial adverse event reports within regulatory and departmental timelines
o Ensures adequacy of recording, summarization, and handling of adverse events for marketed and developmental company products
o Assesses seriousness and expectedness for reported adverse events
o Assesses company causality for relevant adverse events
o Ensures accurate coding of adverse events and serving as a resource to the medical coding staff
- Ensures 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.
AND OTHER JOB DUTIES THAT MAY BE ASSIGNED FROM TIME TO TIME.
- Participate in inspection readiness activities and regulatory inspections
- Provides training on medical topics to the global case management team
- Participates in operational excellence initiatives
- 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.
- The quality of the data collected directly impacts the company's understanding of the drug safety profile.
- Assessment of Risk/Benefit relationship is crucial to any product's success.
- Adherence to pre-determined timelines has a direct impact on regulatory Compliance.
DECISION MAKING, DISCRETION, LATITUDE
- Act decisively on time sensitive issues while adhering to regulations and department SOPs.
- Demonstrate strong ability to prioritize.
- Function with minimal supervision on routine and new assignments.
- Train and mentor new/junior physicians and safety associates.
- Serve as a resource to others in the department for medical questions.
- Demonstrate a high level of global understanding of GSRS processes from Initial Data Intake to Distribution.
MINIMUM EDUCATION REQUIREMENTS
- Graduate of a recognized, accredited medical school.
MINIMUM EXPERIENCE REQUIREMENTS
- Minimum of 3 years' experience in a drug safety surveillance setting within the pharmaceutical/biopharmaceutical industry or in a clinical setting.
KNOWLEDGE & SKILLS
- 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.
skills: GCP (Good Clinical Practice), Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.