Senior Director, Global Patient Safety Operations

2 weeks ago

Redwood City, United States REVOLUTION Medicines Full time

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

We are seeking a highly skilled and experienced Senior Director of Global Patient Safety Operations to join our dynamic team. The Senior Director of Global Patient Safety Operations provides leadership and oversight to the Global Patient Safety department, including implementing the Safety database, overseeing pharmacovigilance vendors, and serving as an internal subject matter expert, furthering the development and implementation of the pharmacovigilance system in support of Revolution Medicines research, development and marketed products.

The successful candidate will take a leadership role in our Safety Operations department, overseeing the safety case processing and management of the department in support of our drug products throughout their lifecycle. This critical role will involve strategic leadership, collaboration with cross-functional teams, technical expertise, and vendor management skills to ensure compliance with regulatory requirements to safeguard patient well-being.

  • In collaboration with senior leadership, develop and implement the Revolution Medicines safety operations strategy, vision, and direction, including the safety database strategy.
  • Manage the safety operations team ensuring case processing activities from all sources follow global regulations and internal requirements, create and analyze oversight metrics reports, review, approve, and trend late case investigations, ensure proper training is received and documented, and ensure the global safety database configuration is appropriate to meet Revolution Medicines needs.
  • Oversee the resourcing, budget, and management of pharmacovigilance contract research organizations (PV CROs) in safety operations activities.
  • Partner with safety science and other development staff as necessary for medical review and approval of cases inclusive of case narratives and causality assessments of AE/SAE reports.
  • In collaboration with safety science and other development staff, compile analysis of similar events (AOSE), individual case comments, REMS (Risk Evaluation and Mitigation Strategies), RMP (Risk Management Plan) analyses, and ad hoc safety analysis as required by health authorities or corporate policy.
  • Contribute to the preparation of aggregate safety reports required by health authorities.
  • Author, review and provide input and approval for drug-safety related regulatory reports and clinical study documents (including case report forms, 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.
  • Develop and maintain relationships across Revolution Medicines, particularly in Clinical Operations, Clinical Development, Clinical Data Science, Regulatory Affairs, Quality Assurance, Medical Affairs, and other departments as appropriate.
  • Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities.
  • Develop standard operating procedures for safety and internal compliance.
  • Oversee as applicable, safety vendors responsible for drafting and submitting periodic reports such as the DSUR (Development Safety Update Report) and PBRER (Periodic Benefit Risk Evaluation Report), ensuring compliance with regulations and timeliness of submission.
  • Collaborate with Safety Science to create robust processes to maintain compliance with safety requirements related to REMS/RMP.
  • In conjunction with the clinical data science and clinical operations, coordinate periodic reconciliation of the clinical and safety databases.
  • Create and maintain the Pharmacovigilance System Master File (PSMF) to support European filings and regulations as applicable.
  • Work with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure European compliance as applicable.
  • Author, review, and approve pharmacovigilance agreements (PVAs), and safety data exchange agreements (SDEA) with applicable partners.
  • Responsible for ensuring inspection readiness for global inspections by ensuring all processes and training reflect global regulatory requirements.
  • Influences and communications with executive management regarding PV strategy
Required Skills, Experience and Education:
  • Bachelor's degree required. Advanced degrees in pharmacy, medicine, nursing, life sciences, or a related field preferred.
  • Extensive experience (10+ years) in drug safety/pharmacovigilance within the pharmaceutical or biotechnology industry, with knowledge of safety operations, GCP, GVP, clinical trial conduct, data interpretation, process management, quality management, data interpretation, data interpretation, and safety's role in clinical development.
  • A history of progressive leadership responsibilities.
  • In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).
  • Strong leadership and management skills, with a track record of building and developing high-performing teams.
  • Excellent written and verbal communication, interpersonal, and influencing skills, with the ability to effectively collaborate with internal and external stakeholders.
  • Proven ability to think strategically, drive innovation, and implement process improvements in drug safety operations.
  • Experience interacting with regulatory agencies and participating in regulatory inspections and audits is required.
  • Expert knowledge of US, EU, and global regulations governing pharmacovigilance.
  • Expert knowledge of industry standard safety databases.
  • Strong program management skills enabling efficient planning and execution of program milestones within budget and timelines.
  • Strong vendor management skills with experience managing high profile projects with CROs and internal staff.
  • Ability to build relationships and influence across disciplines, functions, and levels.
  • Strong learning orientation and the desire to share expertise and learn from others.
  • Commitment to patients and the science that drives the shared mission at Revolution Medicines.
Preferred Skills, Education, and Experience:
  • Advanced degrees in pharmacy, medicine, nursing, life sciences, or a related field preferred.

The base salary range for this full-time position is $240,000 to $294,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.

#LI-Hybrid #LI-SH1

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