Director, CX Learning & Knowledge
Rula
Executive Director – Head of Pharmacovigilance
Generate Biomedicines
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $281,000 - $422,000 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Set and lead the pharmacovigilance strategy and roadmap for Generate’s clinical and development programs.
- Ensure proactive risk management and compliance with local and international PV regulations
- Drives safety related content of regulatory submissions including reference safety information/IB, protocol, informed consent (DSURs, RMPs), and responses to health authorities
- Leads policy discussions to assure communication of benefit-risk considerations and safety surveillance activities including routine review of safety data to detect and evaluate safety signals.
- Oversee pharmacovigilance vendors and CROs to ensure consistent quality and inspection readiness.
- Build and evolve internal PV processes, systems, and SOPs in collaboration with Quality, Regulatory, and Clinical Operations.
- Collaborate cross-functionally with Clinical, Clinical Operations, Regulatory, and Biostatistics.
- Collaborates with medical to define risk-benefit profiles
- Serves as Generate's PV point of contact in regulatory meetings, inspections and internal audits.
- Serve as key member of safety governance committees, including presentation of safety issues, signal evaluations and proposed risk mitigation strategies.
- Mentor and grow a high-performing PV team, including the Sr. Director of PV and future leaders.
Requirements
- MD required.
- 10+ years of experience in pharmacovigilance or drug safety, with at least 2-3 years in leadership roles spanning early and late-stage development.
- Strong knowledge of GCP, GVP, and global PV regulations.
- Expertise in biologics and experience in multiple therapeutic areas, including immunology.
- Proven success leading PV teams and cross-functional safety strategies.
- Experience in regulatory authority interactions and inspections.
- Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical/pharmaceutical information and safety data to both healthcare professionals (HCPs) and non-HCPs.
- Strong organizational, decision-making, and communication skills.
Benefits
- Annual bonus
- Equity compensation
- Competitive benefits package
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmacovigilancedrug safetyGCPGVPglobal PV regulationsbiologicssafety data reviewrisk mitigation strategiessafety signal evaluationclinical data synthesis
Soft skills
leadershiporganizational skillsdecision-makingcommunication skillsmentoringcross-functional collaborationstrategic planningrisk managementproblem-solvingpresentation skills
Certifications
MD
