Director – Safety, PV Operations Lead
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Safety-PV Operations Lead managing global pharmacovigilance operations for Prilenia’s neurodegenerative therapies. Overseeing safety vendors, regulatory documents, signal management, and risk mitigation for late-stage development and commercialization.
Responsibilities:
- Provide strategic direction and manage global safety operations for Prilenia
- Develop and maintain safety operational documents with partners, including Joint Operating Guides, Safety Management Plans, and Safety Data Exchange Agreements
- Coordinate generation of core safety documents, including DSUR, RSI in IBs, CCSI, and RMP/REMS, in consultation with Regulatory Affairs
- Arrange high-quality safety outputs with Biostatistics, QA, and external vendors
- Support ongoing safety monitoring, signal management, and periodic reporting
- Serve as principal point of contact for Prilenia’s safety vendors and manage work orders, budgets, and administrative tasks
- Ensure vendor safety KPIs are met, compliance with Safety Management Plans is maintained, and risk mitigation measures are implemented
- Establish safety procedures, governance models, and SOPs; work with QA on training rollout and documentation
- Work closely with the Head of Global Medical Safety
- Represent Safety Operations at governance and decision forums
- Partner with Regulatory Affairs, PV QA, and medical writing to maintain regulatory and safety compliance
- Represent Prilenia toward development/commercialization partners regarding Safety Operations
- Participate in clinical trial teams and expanded access programs
Requirements:
- Advanced degree (PhD, PharmD, MSc) in a life-science or medical subject
- At least 5 years of experience in a similar pharmacovigilance position
- Significant experience in both small biotechnology and larger pharmaceutical companies
- Experience in late-stage development and initial commercialization
- Experience with compassionate use/expanded access
- In-depth knowledge of global safety requirements, including GVP and CFR 11
- Experience with safety systems, including ARGUS, VEEVA, and MedDRA
- Experience managing external partners and vendors
- Experience with pre- and post-marketing safety/pharmacovigilance requirements
- Experience creating and maintaining CCSI and initial RMP/REMS
- Experience dealing with regulators, including FDA, Health Canada, and EMA PRAC, on risk management plans and risk minimization activities
- Excellent written and verbal communication skills
- Hands-on approach to problem solving and willingness to take responsibility for getting documents in place
- Ability to work independently and collaboratively in a team environment
- Valid driver's license required
- Ability to travel up to 70% domestically/regionally, with some international travel
Benefits:
- Full-time remote position
- Flexible schedule
- Highly virtual and flexible organization
- Flexible ways of working
- Equal opportunity, diverse, inclusive, and welcoming workplace
Similar Jobs
Creative Ops Coordinator
Creative operations coordinator ensuring compliant, correctly tagged ad delivery for Everyday Dose’s functional coffee brand. Managing high-volume asset trafficking, QC, and pipeline operations across Meta, TikTok, and YouTube.
Operations Analyst
Analista de Operações coordenando cronogramas, faturamento e entregas de materiais MPDV. Gestão de envios para ações de trade em São Paulo.
Operations Specialist
Operations Specialist providing interim Executive Director leadership across senior living communities. Improving staffing, financial performance, compliance, training, and resident care across a five-state portfolio.
Market Operations Manager
Market Operations Manager optimizing Game Lounge’s iGaming affiliate sites in Malta. Coordinating content, SEO, compliance, UX, AI workflows, and commercial performance.
Administrative Operations Apprentice
Administrative Operations Apprentice at LeoLabs, mapping orbital activity with radar and AI analytics. Supporting recruiting coordination, Greenhouse data, scheduling, reporting, and process improvement through SkillBridge.
Operations Specialist I – III
Operations Specialist managing time-critical freight orders for Airspace, a tech-enabled freight forwarder. Tracking shipments, coordinating drivers and flights, and proactively updating customers.
Operations Associate – CX
WorkMotion Operations Associate resolving client invoices, platform issues, and customer inquiries. Improving CX operations for companies hiring and managing international talent.
Director, Operations
Director overseeing utilization review and IRO operations for Nexus Enterprises and ProPeer Resources. Managing teams, budgets, compliance, quality improvement, and operational performance.
Bank Fraud Operations SME
Bank fraud operations SME advising Gratia's banking client on a survey of 500+ financial crime executives. Translating survey findings into operational and strategic fraud-industry insights.
eCom Operations Manager
eCom Operations Manager scaling systems and execution for a fast-growing DTC health and wellness brand. Owning SOPs, supply chain coordination, process improvement, and cross-team operations.
Operations Manager – Medical Records Retrieval
Operations Manager leading medical-record retrieval teams for Sharecare’s digital health platform. Managing clients, quality, staffing, financial performance, and operational improvement.
Operations Manager
Operations Manager overseeing data-driven strategy and process improvement for Centene, a national healthcare solutions provider. Improving operational metrics, quality, costs, and member satisfaction across remote U.S. teams.
Test Support Operations Associate – English, French
Test Support Operations Associate running Acuity Insights’ Casper assessment operations for higher education applicants. Preparing test cycles, resolving issues, supporting applicants, and improving operational processes.
Country Operations Associate
Country Operations Associate supporting clinical trial operations for Syneos Health, a life sciences services organization. Managing site activation, regulatory submissions, study documentation, contracting, tracking, and compliance.
Senior Data Operations Coordinator
Senior Data Operations Coordinator overseeing Nielsen’s audience-measurement field data operations in Indonesia. Supervising interviewers, monitoring quality, managing workflows, and delivering performance reports.
Customs Operations Specialist
Customs Operations Specialist managing EU export documentation, customs compliance, and complex shipments for Xometry’s digital manufacturing marketplace. Improving customs workflows through ERP automation and cross-functional collaboration.
Customs Operations Specialist
Customs Operations Specialist managing EU export documentation, customs compliance, and complex shipments for Xometry’s digital manufacturing marketplace. Improving export workflows through ERP collaboration and automation.
Customs Operations Specialist
Customs Operations Specialist managing EU export documentation, customs compliance, and complex shipments. Supporting Xometry’s digital manufacturing marketplace through broker coordination, HS classification, and process automation.
Customs Operations Specialist
Customs Operations Specialist supporting Xometry’s digital manufacturing marketplace and EU export operations. Managing customs documentation, brokers, HS classification, non-standard shipments, and compliance process automation.
Health Plan Operations Partner
Health plan operations partner helping Evio, a specialty-pharmacy solutions company, strengthen customer relationships. Leading advisory forums, CRM processes, medication-contract adoption, and annual planning.