Director – Safety, PV Operations Lead

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Prilenia

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $43M Series B on 2021-11

Healthcare • Biotechnology • Pharmaceuticals

Prilenia is dedicated to developing new treatments for patients and families facing neurodegenerative diseases and neurodevelopmental disorders, such as Huntington’s disease and amyotrophic lateral sclerosis (ALS). They focus on harnessing the brain's neuroprotective capabilities, particularly through the activation of the sigma-1 receptor (S1R), to restore impaired pathways in the brain. Prilenia is advancing scientific research and exploring potential treatments to provide hope and improve the lives of patients and their families.

📋 Description

• 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