Medical Director, Global Risk Management & Safety Surveillance
Iselin, NJ US
The Consultant Medical Director, Global Risk Management and Safety Surveillance (GRMSS), will be responsible for developing and ensuring execution of all patient safety risk management and pharmacovigilance activities for the assigned molecular entities under clinical development as well for marketed products. This may include CSR development, ISS/ SCS development, CO development, and other necessary documents for Type II variations. For an MAA submission or Type II variation, oversee and contribute to the development and/or update of the RMP. The position will require strong oversight for patient safety issues that arise at both the individual case safety report and aggregate levels, strong analytic and decision-making skills on all issues involving safety assessment and surveillance, and effective communication of safety information and messaging to internal and external stakeholders.
Summary of the Essential Functions of the Job
- Lead/ co-lead Safety Management Team and direct all safety risk management activities for assigned products including RSI updates for the Investigator Brochure.
- Ensure local and global risk management plan preparation and execution throughout a medicinal product's lifecycle
- Manage and monitor benefit-risk evaluations to ensure favorable balance
- Medically review individual case safety reports (ICSRs) when necessary and provide follow-up guidance to the case management team to ensure consistent high-quality ICSRs
- Review periodic literature surveys of new and important information regarding products, as well as relevant products from collaboration partners, potentially impacting human safety,
- Drive preparation of IND Annual Reports and/or DSURs for clinical trial programs, and PADERs and/or PSUR/PBRERs for marketed products
- Participate significantly in the development and production of integrated summaries of safety, clinical overviews, and other registration documents for new and supplemental NDAs and/or ex-US new drug submissions for late-phase drug development candidates and marketed products (including EMA marketing variations) in conjunction with Clinical Development, Medical Writing, Statistics, and Regulatory Affairs
- Drive the safety strategy for Reference Safety Information for products, including Investigator Brochures and new or updated ADR labeling (USPI or CDS) for marketed products in the context of multidisciplinary groups within or joint committees between external partners
- Contribute to preparedness for regulatory authority inspection and internal audits of GPRM or other departments with which GPRM collaborates on inspections/audits.
- M.D. Or US/international equivalent
- At least 5 years total pharmaceutical/biotechnology industry experience, of which >5 years will have been in a pharmacovigilance or risk management role
- In-depth knowledge of US/EU risk management/GVP landscape
- First-hand experience interacting with regulators with risk management issues
- Experience as an active contributor with drug registrations (CSRs, ISS, Clinical Overview)
- Training or experience in oncology or inflammatory diseases, or clinical safety support of oncology, immunomodulatory, or other related products
Highly Preferable (but not an absolute requirement):
- M.P.H. Or relevant epidemiology experience in industry or academia
- Board certification in internal medicine or pediatrics (primary care) or hematology/oncology (specialty)
- Experience in pharmaceutical industry activities outside the United States
- Experience in clinical trial development and execution
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.