The Associate Vice President of Pharmacovigilance will be responsible for leading the strategic management, planning, and execution of the Pharmacovigilance and function within the organization, including supervising key pharmacovigilance personnel and overseeing PV activities performed by vendors. You will work with key stakeholders within the organization to develop PV infrastructure, processes, and strategy across Rocket’s pipeline of innovative gene therapies for rare and devastating disorders. You will ensure operational efficiency, provide the highest level of compliance with all regulatory obligations, and lead a highly strategic function that guides Rocket Pharmaceutical’s approach to drug development, submissions, and approved medicines from a safety perspective. This includes proactively identifying and communicating emerging potential and/or urgent safety issues and supporting signal detection, risk/benefit evaluation and creating product risk management plans. This position will be responsible for the management and conduct of all Risk Management and PV activities and operations, whether internally conducted or outsourced.  You will have oversight of individual and aggregate case report processing and ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP). The role requires both a “hands on” and a strategic mind-set. 

• Develop overall risk management plans, pharmacovigilance strategies, risk minimization activities, and contribute to the assessment of risk/benefit for gene therapy products.
• Serve as the PV SME during health authority inspections, maintain safety inspection preparedness, and ensure compliance with GVP, GCP, GMP and all applicable regulations.
• Develop and execute safety and risk management strategy as core team member responsible for new product registration (BLA/MAA filings).
• Chair safety surveillance committee meetings and manage interactions with Safety Review Committees in relevant studies, providing significant strategic input and collaboration regarding IDMC charter and during IDMC meetings.
• Oversee, prepare, and review scheduled periodic/annual reports and INDs, IMPDs per FDA, MHRA and EMA regulations.
• Effectively communicate and collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business to review and provide input to protocols, investigators brochures (IBs), clinical safety reports (CSRs), Informed Consent Forms (ICFs) and other safety-related documents.
• Lead the development of strategies for responding and resolving safety questions from the FDA, EMEA, and other regulatory authorities, and respond to regulatory agency audits.
• Evaluate the changing risk-benefit profile of competitor products in clinical trials as well as commercialized medicines and implement appropriate safety updates and risk mitigation plans for our products, as needed.
• Recognize and escalate significant issues relating to compliance, budgets, timelines or other issues that may jeopardize business objectives.
• Develop and maintain SOPs as needed and ensure compliance by providing training in Pharmacovigilance across the Company.
• Management and approval of budgets/contracts.

• MD preferred; PharmD in related life science area may be considered depending on breadth and depth of pharmacovigilance experience
• Minimum of 10+ years of Drug Safety/Pharmacovigilance experience in a pre-approval setting required, including industry experience with positions of increasing responsibility with experience in managerial oversight.
• Oversight experience of medical safety activities, operations, and risk management strategies in pre and post marketing environments.
• A thorough understanding of the global pharmacovigilance regulatory environment with working knowledge of US and EU regulations, ICH guidelines, and a working understanding of common drug safety databases (e.g. ARGUS), effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective.
• Excellent clinical judgment and ability to communicate complex clinical issues and PV science concepts in a scientifically sound and understandable way.
• Experience working with all levels of management .
• Entrepreneurial, agile and small/high-growth company experience is preferred.
• Experience with new product registration (BLA/MAA filings) and PV infrastructure and process development is preferred.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Ability to work independently and with a team; collaborating and often contributing to discussions amongst internal teams; work effectively without a lot of support or structure.
• Ability to apply expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Ability to be flexible in a fast-paced environment and shift as priorities change.
• Ability to communicate and influence effectively to varied audiences, both internally and externally.
• Establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Thorough understanding of clinical methodologies and providing sound analytical support; quickly stablish credibility as a reliable resource.
• Domestic and International travel up to 20% may be necessary.

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.