Senior Director, Drug Safety Operations

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

📋 Description

• Direct Drug Safety Operations initiatives and supervise designated team members.

• Guarantee the prompt, precise, and compliant gathering, assessment, processing, review, and reporting of safety data throughout clinical development programs.

• Collaborate with Drug Safety leadership to execute and refine operational processes, governance tasks, and resource planning.

• Spearhead the implementation of the global Drug Safety Operations strategy, operational model, governance framework, goals, and resource plans.

• Manage case intake, triage, processing, medical coding, quality review, ICSRs, SUSAR reporting, and submissions to international regulatory bodies.

• Oversee the governance and management of pharmacovigilance vendors, CROs, safety database providers, and external collaborators.

• Develop and enhance pharmacovigilance procedures, SOPs, work instructions, quality systems, and operational controls.

• Ensure readiness for inspections and assist with regulatory audits, partner inspections, and quality evaluations, including the development and implementation of CAPA.

• Track KPIs, quality metrics, dashboards, and trend analyses to foster continuous improvement.

• Work in partnership with Drug Safety physicians, Clinical Development, Regulatory Affairs, Quality, Medical Affairs, Biometrics, and external partners.

• Assist with aggregate safety reporting, including DSURs, PBRERs, Risk Management Plans, and other regulatory submissions.

• Promote process enhancement, system upgrades, automation, and scalable solutions.

• Build, nurture, and mentor a high-performing Drug Safety Operations team.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or a similar scientific field.

• Over 10 years of experience in pharmacovigilance and drug safety operations within the biotechnology and/or pharmaceutical sectors, with progressively increasing responsibilities.

• Preferred experience in supporting small molecule development programs and/or neuroscience/CNS products in an emerging biotechnology setting.

• Proven experience managing global safety operations, including case processing, Individual Case Safety Reports (ICSRs), SUSAR reporting, and regulatory submissions in a GxP-regulated environment.

• Extensive knowledge of global pharmacovigilance regulations and guidelines, including FDA, EMA, MHRA, ICH, GVP, and relevant international reporting requirements.

• Experience overseeing pharmacovigilance vendors, CROs, and external service providers, including performance management, governance, and compliance oversight.

• Practical experience with safety databases and pharmacovigilance technologies, such as Argus, ArisG, or equivalent systems.

• Familiarity with MedDRA, WHO Drug dictionaries, and E2B(R3) reporting standards.

• Background in supporting clinical-stage development programs and aggregate safety reporting tasks such as DSURs, PBRERs, Risk Management Plans, and associated regulatory submissions.

• Proven capacity to lead and develop personnel, manage conflicting priorities, and perform effectively in a dynamic and fast-paced biotech environment.

• Strong skills in cross-functional collaboration, communication, and stakeholder management across various geographies and organizational tiers.

• Experience in supporting regulatory inspections, audits, and interactions with health authorities.

• Advanced degrees like PharmD, MSN, MPH, or MS in a relevant scientific field are preferred.

🏝️ Benefits

• Company bonus based partly on individual and company performance.

• Company-sponsored 401(k) plan.

• Pension benefits.

• Vacation perks.

• Medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Paid time off and leave of absence benefits.

• Well-being perks, including an employee assistance program, fitness benefits, and opportunities for employee clubs and activities.

• Remote work options with occasional travel requirements.