Location
Rockville, MD | United States
Job description
Director of Safety (Must be an MD – Must be board certified or board eligible)
Rockville-West Central, MD area – Local candidates Only!
The Director of Safety will participate in all aspects of Medical Science involvement in in-house clinical programs and trials. The role will serve as a medical expert during the project delivery lifecycle. The ideal candidate will be responsible for medical safety oversight for investigational products, primarily for medical reviews/assessments of adverse event reports, safety signals, and risk management, as well as support aggregate and final safety reports’ preparation. A background in Pharmacovigilance/Safety (PV) for oncology and autoimmune diseases is required. The position will report to the VP, Clinical Development and work closely with the senior leadership and external CRO to ensure oversight of critical safety along with the management of medical and product inquiries for products under development.
Key Responsibilities:
- Performs medical review and assessment of adverse event reports for clinical trials, adhering to documented procedures and company/vendor timeline.
- Accountable for seriousness, causality, and listed news assessments; medical accuracy and completeness of Individual Case Safety Reports (ICSRs); company comment; MedDRA coding.
- Ensures that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment.
- Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
- Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
- Attends and presents at Investigator Meetings.
- Performs review and clarification of trial-related Adverse Events (AEs)
- May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives.
- May perform medical review of adverse event coding.
- Performs review of the Clinical Study Report (CSR) and patient narratives.
- Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
- Participates in the scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed.
- Escalates safety issues related to company products to the supervisor.
- Works closely with Regulatory Affairs, and other senior leadership to ensure oversight of critical safety issues and benefit-risk assessments.
- Participates in the development and maintenance of risk management plans and REMS (Risk Evaluation and Mitigation Strategy).
- Key member on the Product Safety Committee for presentation of safety issues, signal evaluations, and proposed risk mitigation strategies.
- Provides medical content and review of aggregate safety reports such as Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER), other periodic reports, and final Clinical Safety Report (CSR).
- Contributes to the preparation of relevant regulatory documents and responses to regulatory inquiries.
- Provides consultation for medically related questions from participating vendors, affiliates, and collaborators.
- Uses in-depth knowledge of pharmacovigilance science to provide expertise and insight to cross-functional colleagues as appropriate.
- Monitors and assesses all medical and product inquiry for strategic and life cycle consideration.
Day-to-day responsibilities: 1. SAE reporting, coding and narrative development for oncology/immune therapeutic trials in conjunction with a CRO and Chief Medical Officer
2. Provide in house expertise to ensure safety of patients is maintained
3. Supporting database being built by CRO, supporting trending and analysis
4. Leading internal safety meetings to update different functional groups
Must haves: - MD from accredited institution of Medical Education (board certified preferred; board eligible or OUS equivalent), with oncology and autoimmune diseases background.
- Minimum of 5-8 years of experience in Pharmacovigilance/Drug Safety with development and marketed products in a biopharmaceutical industry setting
- Excellent scientific/clinical and analytical knowledge base, with the ability to assess data and understand the safety/medical implications.
- Demonstrated working knowledge of ICH/GCP and FDA guidelines FDA regulations relevant to patient safety and adverse event reporting, including periodic safety reporting.
- Strong ability to understand and evaluate technical, scientific, and medical information, exposure to clinical data collection, assessment, and analysis.
- Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database experience preferred; ability to learn new computer systems as they are implemented.
- Working knowledge of global drug development, clinical trial processes and pharmacovigilance guidelines.
- Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines.
- Excellent teamwork and collaboration; proficiency in verbal and written communication.
- Working knowledge of oncology/immune trials and frequently seen serious adverse events, checkpoint inhibitors
- Prior experience working with an Oracle based database
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