Drug Safety Temp - Director, Medical Review (MD, ICSR Execution | IC) - Remote New Jersey

Orbis Clinical is seeking a remote-based Temp – Director, Medical Review for 6 months initial contract length.

Job Title: Temp – Director, Medical Review

Location: Remote

Contract: 6 months initial contract length

Description:

This individual will be responsible for providing medical assessment and oversight of individual case safety reports completed by vendors and case processing resources in accordance with applicable regulations and agreements. Ensure that assigned staff are appropriately prepared to support current and anticipated activities for medical review and assessment of reports from global development programs and globally marketed products. Ensure inspection readiness and monitoring quality of the medical aspects of PV deliverables. Incumbent may have a supportive role in audits and health authority inspections.

In this role, a typical day might include:

• With oversight from Lead Medical Reviewer, responsible for providing oversight to CRO individual case medical reviewers.
• Review of all ICSRs including supporting vendor outsource model as directed by Lead Medical Reviewer.
• Provide medical advice and input to the activities of adverse event (AE) case management, including medical review of ICSRs (narrative, coding, labeling, causality, company comment) as well as work closely with PV teams, RM leads and clinical development leads to provide a cohesive, comprehensive and accurate medical narrative, analysis of similar events (when applicable) and company causality rationale in individual case reports prior to health authority submission.
• Serve as resource for medical review of company compounds.
• Skillful management and resolution of issues, which may, depending on complexity, require effective escalation.
• Actively participate in the development and maintenance of relevant SOPs and working practices
• Actively participate in process improvement activities within PV (as applicable)

This role might be for you if can: ​

• Ability to apply and provide critical analysis of relevant clinical information for both clinical trial and post-marketing SAE and AESIs. Function as a medical review expert internal and external to GPS for company compounds. Ability to utilize GPS safety database for purposes of medical case review and simple queries. Ability to effectively communicate (verbal and written) medical rationale and defend recommendations in safety narratives.
• Strong clinical acumen with expertise in individual case reviews. Ability to manage external vendors and liase with companyclinical and risk management team.
• Knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
• Experience with Argus safety database

To be considered for this opportunity, you must have the following:

• MD required (Board Certification preferred)
• Clinical experience required.
• 8+ years of experience across industry and academia and/or patient care settings is required (may include residency and fellowship training), including a minimum of 5 years of industry pharmacovigilance/drug safety experience with significant medical review of individual case safety reports (ICSRs).

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $115.00 – $135 .00 per hour, can vary depending on employment status.
• Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.