VP, National Accounts – Restaurant
Sysco
SFDC
Vice President, Pharmacovigilance and Patient Safety
Day One Biopharmaceuticals
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $370,000 - $395,000 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Serve as the subject matter expert (SME) on global drug safety requirements in all phases of drug development and post-market support, providing leadership in the transition from a clinical stage company into an organization encompassing global post-market drug safety and risk management.
- Represent the Pharmacovigilance and Patient Safety Department across all Day One Bio programs.
- Lead and oversee the fundamental activities of Safety Operations including continuous safety data collection and compliant regulatory reporting.
- Lead and oversee Pharmacovigilance signal detection, risk management activities and risk mitigation strategies throughout the lifecycle of Day One Bio’s products.
- Provide oversight and management of pharmacovigilance agreements (PVAs) and relationship management with Development Partners.
- Ensure ongoing evaluation of the overall safety profile for all of Day One Bio's investigational products and regular presentation of safety data in cross-departmental safety review meetings.
- Identify matters that need escalation upper leadership via internal safety governance processes.
- In coordination with Regulatory Affairs, plan, and support safety input into regulatory submissions including registration product applications and product labeling for the safety sections of the assigned products and indications (e.g., CCSI, USPI).
- Represent the company at Safety meetings and lead responses to and/or resolution of regulatory safety enquiries from regulatory agencies and health authorities.
- Standing member and Deputy Chair of the Safety Review Board for Safety Governance.
- Member of Senior Leadership Team (SLT).
- Provide drug safety expertise and review for the accuracy and quality of all safety sections in pre- and post-approval documents with timely communication of recommendations and/or actions to internal and external stakeholders.
- Support both Clinical Development, Clinical Operations, and Medical Affairs teams with respect to safety related issues as required.
- Participate in planning, review and approval of clinical trial safety documents and aggregate safety reports, (e.g., DSURs, PADERs) including content of clinical protocols and Investigator’s Brochures, annual reports, final study reports and other documents as needed.
- Provide input and review of responses to regulatory agency questions with regard to safety and pharmacovigilance activities.
- Assess global PV requirements for resources, equipment, and systems to maximize efficiency.
- Ensure the thorough collection and reporting of existing safety data from all sources, to allow accurate risk characterization overtime, and maintenance of a positive benefit risk balance for Day One Bio’s product.
- Develop overall risk management plans, pharmacovigilance strategies, and risk minimization activities.
- Ensure robust integrity and maintenance of a global safety database to ensure compliance of the safety system for approved products and products in the Day One Bio portfolio.
- Lead optimization of the current signal detection system to ensure signal identification, evaluation, and validation through product lifecycle and with consideration for global partnership PVA compliance.
- Represent Global Drug Safety at regulatory authority meetings, and at external conferences and conventions.
- Lead cross-functional and cross-departmental interactions with clinical development, medical affairs, regulatory affairs, and commercial groups.
- Collaborate as necessary with business development team to contribute to any due diligence activities.
- Interact and represent safety and pharmacovigilance purposes, representing Company with selected Corporate Partners.
- Hire, develop, and mentor the Pharmacovigilance and Patient Safety team.
- Assess and align the organization to meet the goals of the long-range business plan.
Requirements
- M.D. or D.O. degree required with 15+ years’ experience in a Drug Safety/PV Department in a pharmaceutical/biotech company.
- Therapeutic experience in pediatric medicine, pediatric oncology or adult hematological-oncology, or related therapeutic experience is highly desirable.
- Entrepreneurial, small/high growth company experience preferred.
- Experience leading a multifaceted team of safety physicians, safety systems, and operations personnel and the ability to reevaluate team needs and resources in an evolving company.
- Strong track record of supporting regulatory (IND, NDA/BLA, MAA) and product launch success that entails developing drug safety and PV processes to support the transition of product development into product approval/post-market.
- Solid knowledge of current and emerging regulatory requirements and expectations including GCP, FDA, and EU GVP regulations and international guidelines.
- Extensive Pharmacovigilance management experience in early (First in Human) to the late-stage clinical setting, including oversight of 3rd party drug safety activities, internal pharmacovigilance review processes and drug safety assessments, safety signal detection and identification, reporting procedures, compliance, and risk management.
- Proven Safety lead for US and OUS health authority interactions including pre-NDA/MAA IRs and meetings, review cycle requests, ODAC meetings, and post-marketing requirements.
- Ability to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
- Excellent interpersonal skills, ability to develop strong relationships with key stakeholders, skillful conflict management and negotiation skills, ability to identify issues early and develop relevant and realistic plans, programs and/or recommendations.
- Strong and clear communicator, both orally and with the written format.
- Embrace Day One Bio’s core values and enthusiastically join the mission, inspiring others.
- Kindness, patience, humor, and compassion are all desirable assets to possess and to share with others.
Benefits
- Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
PharmacovigilanceDrug SafetyRisk ManagementSignal DetectionRegulatory SubmissionsAdverse Event ReportingClinical Trial Safety DocumentsSafety Data CollectionComplianceDrug Development
Soft skills
LeadershipInterpersonal SkillsConflict ManagementNegotiation SkillsCommunicationRelationship ManagementTeam DevelopmentProblem SolvingMentoringCollaboration
Certifications
M.D.D.O.
