VP Pharmacovigilance & Drug Safety

Position Summary: 

Reporting to the CMO, the VP Pharmacovigilance & Drug Safety has overall responsibility for drug safety activities for both early and late phase assets as well as contributing to furthering the development and implementation of the clinical development strategy. The VP will be accountable for overseeing safety and pharmacovigilance across development and expected global launches and, ultimately, post-marketed products. The VP must possess a strong knowledge of global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve challenges and facilitate PVG compliance.

Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States.   

Essential Duties and Responsibilities:

DRUG SAFETY SCIENCE

• Provide medical oversight of the PV function including medical review of all cases inclusive of case narratives and causality assessments of AE/SAE reports.
• Create and maintain a signal detection process (including regular and ad hoc reviews of aggregate safety data) for Erasca’s products.
• Coordinate safety governance within the company and ensure cross-functional involvement in the evaluation of potential emerging safety issues and any associated risk mitigation and management measures that are proposed.
• Participate as a key stakeholder in safety analyses and ensure proactive and timely benefit-risk assessments of safety data.
• Represent PVG in communication with health and regulatory authorities including management of the DSUR process.
• Represent PVG at independent Data Safety Monitoring Committee meetings.
• Compile analysis of similar events (AOSE), individual case comments, REMS/RMP analyses, and ad hoc safety analysis as required by health authorities or corporate policy.
• Serve as SME author, reviewer, and approver for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information, etc).

DRUG SAFETY OPERATIONS

• Evaluate current safety operations strategy and determine appropriateness for current and future needs. Requires understanding of pros/cons of various internal and external models of safety operations implementation.
• Manage and direct Drug Safety operations staff to oversee case management functions ensuring process optimization, case quality, and accurate regulatory reporting.
• Work with external partners to jointly manage cases, safety reporting, and signal detection across global development for molecule candidates.
• Optimize utilization of information systems supporting case management (e.g., Oracle Argus).
• Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis.
• Determine processes and/or tools supporting Pharmacovigilance signal management in accordance with GVP.

SAFETY QUALITY MANAGEMENT

• Ensure compliance of the PVG system for all safety data sources in collaboration with cross functional stakeholders.
• Establish complementary GVP/GxP procedures for monitoring compliance with drug safety-related policies, procedures, applicable regulations, and agreements with contractual partners.
• Establish, measure, and report key compliance, quality, and performance indicators (KCI/KQI/KPIs) with cross functional stakeholders.
• Work with Quality to plan, conduct, and document internal and external GVP/GxP audits to assess compliance with applicable regulations, regulatory commitments, company SOPs, protocols, systems and contractual obligations as applicable.
• Manage the operational compliance of key and strategic vendors for partnership, participate in and support audits of contractual partners as necessary.
• Proactively identify procedural gaps and challenges and propose and implement solutions, lead the establishment of business process optimization efforts to ensure efficiency and process improvements with the department.
• Oversee PVG department process and project management efforts.
• Formulate controls in line with GxP partners to maintain a system of third-party vendors to ensure compliance with PVG reporting requirements.

GENERAL

• Build and lead high functioning PVG team utilizing internal and external resources.
• Develop operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met.
• Develop and maintain relationships across Erasca, particularly in Clinical Development, Clinical Operations, Data Management, and Regulatory Affairs.
• Supervise employees directly and indirectly through direct reporting, matrix, or in collaboration with external partners.
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

Required Education and Experience:

• Doctor of Medicine (or x-US equivalent) or PharmD with industry experience in oncology clinical development required. Extensive industry experience and another relevant clinical degree (ie RN, MSN, NP) may be considered.
• 10 or more years of experience in the biotechnology or pharmaceutical industry with knowledge of GCP, clinical trial conduct, data interpretation, and safety in clinical development. A mix of large and small company experience highly preferred.
• In depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation.
• Exposure to early clinical development preferred.
• Extensive experience interfacing with US and x-US health authorities required. Experience with executing clinical trials in China, reporting safety data to China health authorities, and reporting China safety data to ex-China regulatory authorities (e.g. FDA) highly preferred.
• Excellent scientific and clinical and analytical knowledge base, with ability to assess data and understand the safety and medical implications.
• Expert knowledge of the regulations governing pharmacovigilance.
• In depth knowledge of Safety Science and Safety Operations disciplines, with exposure to both internally and externally managed safety systems and databases.
• Direct management experience with proven ability to effectively lead, coach, mentor, and manage others.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Effective interpersonal, communication and influencing skills, including excellent writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.
• Strong learning orientation, curiosity, and commitment to science and patients.

The anticipated salary range for this position is $325,000-385,000,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.