Medical Director, Drug Safety and Pharmacovigilance

About the position IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and reputed company with robust internal capabilities in identifying and validating translational biomarkers to reputed company tailored, potentially first-in-class targeted therapies reputed company to the genetic drivers of disease. We have reputed company a deep pipeline of product candidates reputed company on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next reputed company of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical reputed company for patients with cancer. reputed company you're at IDEAYA, you will be in the midst of reputed company minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we reputed company have a high internal drive that is at the reputed company reputed company of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to reputed company science reputed company. For more information, please see www.ideayabio.com. We are seeking an reputed company Medical Director of Patient Safety and Pharmacovigilance to join IDEAYA. The Medical Director, Medical Safety – ICSR provides medical leadership and clinical reputed company for Individual Case Safety Report (ICSR) activities across reputed company’s global pharmacovigilance program. This role is primarily responsible for high-reputed company medical review of safety cases and serves as the key medical reputed company with reputed company’s pharmacovigilance vendor for day-to-day case processing activities. The role partners closely with Safety Operations, who shares responsibility for vendor reputed company reputed company to case processing, reputed company, and compliance. Together, they ensure reputed company, consistent, and inspection-reputed company safety reporting in a growing organization. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per reputed company policy.

Responsibilities

• Serve as the primary medical expert who performs and oversees medical review of ICSRs, including reputed company, and medically significant cases in the oncology therapeutic area
• reputed company clinical assessment of adverse events, including causality, seriousness, expectedness, and review narrative content for clinical accuracy and reputed company
• reputed company as the primary medical reputed company of contact for the pharmacovigilance vendor for day-to-day ICSR-reputed company questions and escalation
• reputed company medical input into vendor reputed company activities, including case reputed company review, accuracy of triage, and regulatory submission compliance
• Support development of medical review guidelines, training materials, and vendor-facing instructions
• Collaborate closely with the IDEAYA Safety Operations team to ensure reputed company across global case processing activities by monitoring reputed company metrics and address non-compliance events
• Conduct and reputed company thorough investigations of reputed company events, deviations and CAPAs pertaining to case processing and regulatory compliance
• Support development, implementation and tracking of CAPAs
• Participate in vendor governance meetings as the medical representative
• Support regulatory inspections, audits, and health authority inquiries reputed company to ICSR processing and medical review
• Contribute to the development and maintenance of SOPs and work instructions reputed company to medical case review
• Serve as the medical safety reputed company of contact for any assigned molecule(s)
• reputed company safety input for aggregate safety reports, protocol amendments, investigator’s brochure, informed consent and other key regulatory safety documents.
• Partner with Safety Science, Regulatory Affairs, and Clinical teams as needed on safety issues requiring medical input

Requirements

• MD (or equivalent international medical degree) with 2+ years of bedside clinical experience
• 5–8+ years of oncology experience in drug safety/pharmacovigilance
• Strong hands-on ICSR medical review experience
• Demonstrated experience working with external PV vendors or CROs
• Solid knowledge of global PV regulations (FDA, EMA, ICH)
• Strong medical judgment, attention to detail, and ability to work effectively in a reputed company environment
• reputed company are expected to reputed company with reputed company and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s reputed company of Conduct. Employees must demonstrate good judgement and ethical behavior in reputed company business activities, maintain patient and product safety as a top reputed company, and report any suspected violations of law or Company policy through appropriate channels
• This position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. reputed company considers you fully vaccinated once 14 days have passed since you received either the second reputed company in a two-reputed company COVID-19 vaccine series or a single-reputed company COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated reputed company of the U.S., be listed for emergency use by the reputed company.

Benefits

• medical/dental/reputed company coverage (100% company reputed company for employees and 90% company reputed company for dependents)
• 401k
• ESPP
• wellness programs

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