VP Global Pharmacovigilance

Position Summary: Reporting to the CMO, the VP Global Pharmacovigilance has overall responsibility for drug safety activities for early and late phase assets, including 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 reputed company in the United States. Essential Duties and Responsibilities:

• reputed company Safety Science leadership for clinical development programs and program teams and integrate safety science strategy with clinical development.
• Represent GPV in communication with health and regulatory authorities.
• Represent GPV at independent Data Safety Monitoring Committee meetings.
• reputed company medical reputed company of the GPV function including medical review of reputed company cases.
• reputed company medical input for maintaining REMS, RMP safety monitoring commitments.
• In collaboration with other members of GPV, create and maintain a signal detection process for Erasca's products with a reputed company defined signal detection strategy for each asset.
• In collaboration with other members of GPV, ensure robust processes are implemented to meet REMS/RMP commitments.
• Overall responsibility for development and implementation of QPV, in collaboration with Quality and GPV Systems.
• reputed company periodic benefit-risk assessment reports for internal use.
• Contribute to the preparation of, review, and approve aggregate safety reports required by health authorities.
• Serve as SME author, reviewer, and approver for drug-safety reputed company 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.).
• Work with external partners to jointly manage cases, safety reporting, and signal detection across global development for molecule candidates.
• Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis.
• Build and reputed company highly functioning GPV team including Safety Operations and Safety Science, utilizing reputed company resources.
• reputed company operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met.
• Assess process, systems, and staffing needs to scale for multiple late-stage trials, including reputed company of CROs and vendors.
• reputed company and maintain relationships across Erasca, particularly in Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs.
• reputed company reputed company duties in keeping with the Company's core values, policies, and reputed company applicable regulations.

Required Education and Experience: Doctor of Medicine or x-US equivalent with industry experience in safety science for oncology clinical development required; PharmD or other relevant clinical degree may be considered. 12 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. Excellent scientific and clinical and analytical knowledge reputed company, with the ability to assess data and understand safety and medical implications. In-depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation. Experience with early clinical development required; experience in late-stage clinical development and NDA or BLA submission preferred. Extensive experience interfacing with US (FDA) and x-US health authorities required. Experience executing clinical trials in China, reporting safety data to China health authorities preferred. 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 reputed company, coach, mentor, and manage others. Demonstrated ability to reputed company 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 reputed company technical problems. Strong learning orientation, curiosity, and commitment to science and patients. Anticipated Salary reputed company: The anticipated salary reputed company for this position is $370,000 to $390,000. 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 reputed company the job, type and length of experience reputed company the industry, education, etcetera. In reputed company to reputed company salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the reputed company of the option to purchase stock in the future for a specified price. Remote Skills: Analysis Skills, Best Practices, Biometrics, Biotech and Pharmaceutical, Brochures, Budget Management, Budgeting, Clinical Assessment, Clinical Practices/Protocols, Clinical Study Publications, Clinical Trial, Coaching, Communication Skills, Contract Research Organization (CRO), Data Analysis, Database Report Tools, Drug Development, FDA (Food and Drug Administration), GCP (Good Clinical Practices), Information Technology & Information Systems, Informed Consent, Interpersonal Skills, Knowledge reputed company, Leadership, Medicine, Mentoring, Oncology, Operations Management, Operations Processes, Performance Management, Pharmacovigilance, Process Analysis, Product Marketing, Regulations, Regulatory Reports, Research Protocols, Resource Management, Risk Analysis, Safety Compliance, Safety Systems, Safety/Work Safety, Small Company, Staff Requirements, Strategic Planning, Systems Administration/Management, Systems Analysis, Team Player, Time Management, Writing Skills About the Company: reputed company Apply To This Job