Senior Director, Drug Safety and Pharmacovigilance (Remote)

The Senior Director, Drug Safety and Pharmacovigilance (DSPV) is responsible for identifying and assisting in the management of safety concerns with the drug product(s) owned by the company. This role ensures that any safety signals are appropriately evaluated, communicated, and managed. In addition, this role will participate in any commercial reporting and developing processes as needed. This role is also responsible for writing documents required for assessment and communication of product safety information for core safety documents. This is a remote-based position located in the United States. Responsibilities:

• Responsible for providing oversight and management of activities pertaining to Elevar's product safety and pharmacovigilance in clinical development and post-marketing surveillance
• Oversee and is responsible for the integration of pre-and post-marketing safety surveillance with Clinical Development and Medical Affairs activities and for ensuring an integrated and proactive approach to risk management
• Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment and clinical trial data interpretation
• Ensure processes within DSPV are conducted in accordance with corporate Standard Operating Procedures (SOPs), department SOPs, guidelines and applicable regulations
• Oversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations
• Chair for the Drug Safety Council, Safety Data Review Team, and Safety Management Team meetings and participate in Joint Safety Meetings with partners
• Oversee development and compliance of Safety Data Exchange Agreements (SDEA) and Pharmacovigilance Agreements (PVA) with partners
• Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues, including contributing authorship and review of Investigator Brochures, development plans, clinical protocols, INDs/CTAs, regulatory responses and risk management plans. (e.g. Clinical Safety Reports, NDAs, Integrated Summary of Safety, etc.)
• Support and/or draft regulatory inquiry responses related to DSPV issues to regulatory agencies, EC/IRB, Investigators and ad hoc inquiries
• Provide oversight and input to aggregate safety reports (e.g. development safety update reports, periodic benefit risk evaluation reports) as appropriate for DSPV relevance
• Manage literature searches and review and able to effectively determine appropriate and relevant literature for safety analyses in collaboration with the Safety Scientist
• Support the conduct of DSPV internal & external audits and regulatory inspections and ensure audit and inspection readiness of the function at all times

Requirements

• Bachelor's degree with 15+ years; Master's degree with 12+ years; or PhD with 8+ year's experience. Proven strategic management experience demonstrating business acumen, developing and delivering strategy and vision, delivering results, championing innovation, coaching and developing subordinates, including remote teams.
• MD or DO is required
• Minimum of 10 years in drug safety activities is required with both Clinical and Post-Marketing PV Physician experience, oncology experience preferred
• Experience in communicating with the FDA. Working knowledge of relevant FDA, EU, International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing both safety reporting and processing for clinical trial environments
• Strategic management experience, delivering results, championing innovation, coaching and developing individuals and teams in person and remotely
• Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels
• Working knowledge of MedDRA dictionary and WHO Drug Dictionary. Experience with MedDRA coding, Analysis of Similar Events, and Standardized MedDRA Queries (SMQs)
• Experience with Argus safety databases
• Knowledge of Individual Case Safety Reports (ICSR) management processes
• Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a remote team
• Management experience as this position has direct reports
• 20% travel is required
• Ability to demonstrate Elevar's core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making spaces for ingenuity in work and thought, and staying grounded in compassion

The anticipated annual base salary range for this role is $299,000 to $340,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees. #LI-REMOTE Apply tot his job Apply To this Job