What are the responsibilities and job description for the Director, Pharmacovigilance position at Rocket Pharmaceuticals?
Overview
Work at ROCKET PHARMA and help cure rare diseases!
Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
Position Summary
This position provides the medical safety leadership needed to perform independent medical review of safety information from any source to evaluate medical contents and proactively identify potential safety signals at both single and aggregate case level. This position also leads safety activities and independently develops benefit-risk strategies for assigned program(s), including chairing the Safety Surveillance Committee(s) and actively participating in Independent Data and Safety Monitoring Committee(s). In addition, this position leads the preparation of aggregate safety documents as well as safety sections of relevant clinical trial documents and regulatory filings.
Responsibilities
• Lead safety activities and benefit-risk strategies for assigned programs by chairing the Safety Surveillance Committee(s) and actively participating in Independent Data and Safety Monitoring Committee(s) for assigned investigational products.• Provide independent medical input and lead the preparation of aggregate reports (PBRER, DSUR, 120-day safety update reports), safety sections of relevant clinical trial documents (e.g., protocols, clinical study reports, investigator brochures, informed consent forms), and regulatory filings (e.g., clinical trial applications, marketing authorization applications) including statistical analysis plan, safety table shells, and integrated safety data review.• Serve as safety medical expert to lead the evaluation of adverse events for all assigned programs from any source, including providing company causality assessment aligned with global regulations, determining whether the events are accurately reported and captured, and confirming events are correctly coded with MedDRA.• Lead responses to safety queries from regulatory authorities as needed, including independently developing safety strategies and performing safety analyses using appropriate data sources.• Lead the development of safety strategies, in close collaboration with cross-functional teams, for pre-submission meetings, Advisory Committee meetings, and Scientific Advice meetings. • Lead the development and implementation of safety strategies for risk management plans and post-approval safety commitments including additional PV activities, risk minimization measures, and non-interventional safety studies. • Provide PV leadership to clinical development project teams and submission teams by providing expert medical guidance on safety matters for investigational products. • Lead the signal management system with regular independent review of safety data for assigned products and detection and evaluation of new safety signals.• Conduct medical evaluation of relevant safety-related information from toxicology and non-clinical studies.• Provide oversight of safety vendors and serve as back-up for the Head of PV.• Lead continuous improvement activities of self as well as for PV department including systems design and quality management activities. • Provide PV leadership to ensure inspection readiness including evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
Qualifications
• MD required. Postgraduate qualification or experience in hematology/oncology or related specialty desirable.
• 10 years of PV experience is required. • Ability to apply PV science expertise to independent evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product. • Expertise in leveraging available tools and PV strategies to investigate safety concerns. • Extensive understanding of regulatory requirements for safety assessment and action. • Strong scientific analytical reasoning skills. • Ability to work on multiple projects in parallel. • Excellent attention to detail. • Proven track record of PV leadership and ability to collaborate effectively on cross-functional teams.• Excellent verbal and written communication skills.
EEO Statement
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.