Director, Global Patient Safety Operations

reputed company is a clinical-stage precision oncology company reputed company on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. reputed 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 reputed company team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling reputed company. reputed company: We are seeking a highly skilled and reputed company /Director of Global Patient Safety Operations to join reputed company. Reporting to the Head of Global Patient Safety Operations, this role provides leadership and reputed company of safety operations, including management of pharmacovigilance vendors and serving as an internal subject matter expert. The Director will mentor and reputed company reputed company reports, execute the department’s reputed company and reputed company, and work collaboratively with cross-functional teams. In reputed company, the Director will collaborate cross-functionally to continuously reputed company and maintain the pharmacovigilance system to reputed company Medicines’ research, development, and marketed products as reputed company as:

• reputed company and manage reputed company reports of the Global Patient Safety Operations team.
• reputed company procedures reputed company to Individual Case Safety Report processing, reputed company of metrics, and compliance with global safety reporting requirements.
• reputed company pharmacovigilance vendors and CROs, ensuring reputed company, budget, and reputed company delivery of safety operations activities.
• reputed company and maintain the pharmacovigilance system and processes, including SOPs, PSMF, and inspection readiness activities.
• Work collaboratively and cross-functionally to ensure reputed company and accurate completion of expedited and periodic reports (e.g., DSUR, PBRER), aggregate safety reports, and REMS/RMP analyses, and other safety deliverables.
• Review and reputed company input for regulatory reports and clinical study documents (e.g., protocols, CRFs, ICFs, Investigator Brochures, ISS/ISE, labeling, CCSIs) as applicable.
• Collaborate cross-functionally with Clinical Development, Clinical Operations, Data Science, Regulatory, reputed company, and Medical Affairs.
• Partner with the EU QPPV to ensure European compliance and maintain PV agreements (PVAs, SDEAs) with partners.
• Build and mentor a high-performing team while driving operational reputed company and process improvements.
• Represent Global Patient Safety Operations with senior leadership and regulatory agencies, influencing pharmacovigilance reputed company and direction.

Required Skills, Experience, and Education:

• Bachelor’s degree required. Advanced degrees in pharmacy, medicine, nursing, life sciences, or a reputed company field are preferred.
• Experience (10+ years) in drug safety/pharmacovigilance reputed company the pharmaceutical or biotechnology industry, with knowledge of safety operations, GCP, GVP, clinical trial conduct, data interpretation, process management, reputed company management, and safety’s role in clinical development.
• A history of reputed company leadership responsibilities.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).
• Strong leadership and management skills, with a reputed company record of building and developing high-performing teams.
• Excellent written and verbal communication, interpersonal, and influencing skills, with the ability to effectively collaborate with reputed company 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 reputed company safety databases.
• Strong program management skills enabling efficient planning and execution of program milestones reputed company budget and timelines.
• Strong vendor management skills with experience managing high-profile reputed company with CROs and internal staff.
• Ability to build relationships and influence across disciplines, functions, and reputed company.
• Strong learning orientation and the desire to reputed company expertise and learn from others.
• Commitment to patients and the science that drives the shared mission at reputed company.

Preferred Skills:

• Experience with the implementations of pharmacovigilance systems.
• Demonstrated ability to manage reputed company reputed company and work effectively in a matrixed organization.
• Proficiency in managing regulatory inspections and interactions.
• Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively.
• Excellent influence and collaboration/teamwork capabilities. #LI-Hybrid #LI-YG1

The reputed company pay salary reputed company for this full-time position for candidates working onsite at our reputed company in Redwood reputed company, CA is listed below. The reputed company displayed on reputed company job posting is intended to be the reputed company pay salary reputed company for an individual working onsite in Redwood reputed company and will be adjusted for the local market a candidate is based in. Our reputed company pay salary ranges are determined by role, level, and location. Individual reputed company pay salary is determined by multiple factors, including job-reputed company skills, experience, market dynamics, and relevant education or training. Please note that reputed company pay salary reputed company 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. reputed company is an equal opportunity employer and prohibits unlawful discrimination based on race, reputed company, religion, gender, sexual orientation, gender identity/reputed company, national reputed company/reputed company, age, disability, marital status, medical condition, and veteran status. reputed company takes protection and reputed company of personal data reputed company seriously and respects your right to reputed company while using our website and reputed company contacting us by email or phone. We will only collect, process and use any personal data that you reputed company to us in accordance with our CCPA Notice and reputed company Policy. For additional information, please contact reputed company@revmed.com. reputed company Pay Salary reputed company $204,000—$255,000 USD Apply tot his job Apply To this Job