Executive Director

Description:

The Executive 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 and development and marketed products.

We are seeking a highly skilled and experienced Head of Global Patient Safety Operations to join our dynamic team. The successful candidate will lead 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.

Develop and implement the Revolution Medicines safety database strategy.
Lead 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.
Lead development of standard operating procedures for safety and internal compliance.
Oversee as applicable, safety vendor 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.

Required Skills, Experience and Education:

Bachelor’s degree required. Advanced degree in pharmacy, medicine, nursing, life sciences, or a related field preferred.
Extensive experience (10-12 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, 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.