Director – Pharmacovigilance

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

📋 Description

• Oversee and enhance the pharmacovigilance safety function.

• Provide direct support to a dedicated team and manage operations comprehensively.

• Drive risk management and mitigation strategies for assigned products.

• Conduct safety data reviews and analyses for all products.

• Generate safety-related content for clinical and regulatory documentation.

• Prepare for pharmacovigilance inspections and represent the organization during regulatory audits.

• Track regulatory developments and revise SOPs and documentation to close process gaps.

• Assess resource and infrastructure needs while contributing to departmental budgeting and planning.

• Represent product safety in cross-functional teams.

• Oversee safety governance with medical monitors and organizational leadership.

• Coordinate safety activities for regulatory submissions, including meeting requests, briefing documents, SAP and TFL evaluations, signal detection, risk identification, regulatory inquiries, RMPs, REMS, ISS strategies, and regional safety labeling.

• Mentor team members within the pharmacovigilance department.

⛳️ Requirements

• Advanced degree in a biological, medical, clinical, or nursing field: Pharmacist/PharmD, Nurse Practitioner, MD, or PhD.

• A minimum of 10 years of experience in drug safety, safety science, and risk management within a pharmaceutical, biotech, or CRO setting, including leadership roles.

• Familiarity with US and EU safety regulations and pharmacovigilance requirements both pre and post-marketing.

• Experience in pharmacovigilance risk management, preferably in a commercial-stage organization.

• Expertise in preparing safety regulatory documentation for pre-marketing and post-marketing phases, including PSURs, PBRERs, PADER, and Risk Management Plans.

• Background in clinical development, risk/benefit analysis, and safety assessments.

• Strong skills in clinical analysis, problem-solving, scientific writing, and communication.

• Previous involvement in BLA/NDA submissions.

• Hands-on approach and capability to thrive in a small biotech environment.

• Proficiency in analyzing safety data from clinical and safety databases.

• Experience with MedDRA coding and strategies for searches.

• Exceptional independent judgment grounded in knowledge and expertise.

• Strong personal time management and project management abilities.

🏝️ Benefits

• Pre-IPO equity.

• Annual bonus.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• Paid time off (PTO).

• 401(k) plan.

• Life and accidental death and disability coverage.

• Parental leave benefits.

• Subsidized daily lunches and snacks at on-site locations.