Director – Safety, PV Operations Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic leadership and oversee global safety operations for Prilenia.

• Create and maintain safety operational documentation with partners, including Joint Operating Guides, Safety Management Plans, and Safety Data Exchange Agreements.

• Coordinate the development of essential safety documents, such as DSUR, RSI in IBs, CCSI, and RMP/REMS, in collaboration with Regulatory Affairs.

• Ensure high-quality safety outputs by collaborating with Biostatistics, QA, and external vendors.

• Assist in ongoing safety monitoring, signal management, and periodic reporting activities.

• Act as the primary liaison for Prilenia’s safety vendors, managing work orders, budgets, and administrative responsibilities.

• Ensure that vendor safety KPIs are achieved, compliance with Safety Management Plans is upheld, and risk mitigation strategies are effectively implemented.

• Establish safety protocols, governance frameworks, and SOPs; collaborate with QA on training implementation and documentation.

• Work closely with the Head of Global Medical Safety.

• Represent Safety Operations in governance and decision-making forums.

• Collaborate with Regulatory Affairs, PV QA, and medical writing to ensure regulatory and safety compliance.

• Represent Prilenia to development/commercialization partners concerning Safety Operations.

• Engage actively in clinical trial teams and expanded access initiatives.

⛳️ Requirements

• Advanced degree (PhD, PharmD, MSc) in a life science or medical discipline.

• Minimum of 5 years of experience in a comparable pharmacovigilance role.

• Extensive experience in both small biotechnology firms and larger pharmaceutical companies.

• Background in late-stage development and initial commercialization.

• Familiarity with compassionate use/expanded access programs.

• Comprehensive understanding of global safety regulations, including GVP and CFR 11.

• Proficiency with safety systems such as ARGUS, VEEVA, and MedDRA.

• Experience in managing external partners and vendors.

• Knowledge of pre- and post-marketing safety/pharmacovigilance requirements.

• Background in creating and maintaining CCSI and initial RMP/REMS.

• Experience interacting with regulators such as the FDA, Health Canada, and EMA PRAC regarding risk management plans and risk minimization strategies.

• Exceptional written and verbal communication abilities.

• Proactive problem-solving approach and a commitment to ensuring documentation is in place.

• Capability to work independently as well as collaboratively within a team setting.

• Valid driver's license required.

• Willingness to travel up to 70% domestically/regionally, with some international travel.

🏝️ Benefits

• Full-time remote position.

• Flexible schedule.

• Highly virtual and adaptable organization.

• Flexible working arrangements.

• Equal opportunity, diverse, inclusive, and welcoming workplace.