Senior Director, Drug Safety Operations

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

📋 Description

• Oversee Drug Safety Operations activities and manage designated team members.

• Ensure the prompt, precise, and compliant collection, evaluation, processing, review, and reporting of safety information throughout clinical development programs.

• Collaborate with Drug Safety leadership to implement and enhance operational processes, governance activities, and resource planning.

• Direct the execution of the global Drug Safety Operations strategy, operational model, governance framework, objectives, and resource allocation plans.

• Supervise case intake, triage, processing, medical coding, quality review, ICSR and SUSAR reporting, along with submissions to global regulatory authorities.

• Manage pharmacovigilance vendors, CROs, safety database providers, and external partners.

• Develop and refine pharmacovigilance processes, SOPs, work instructions, quality systems, and operational controls.

• Ensure readiness for inspections and lead support for regulatory inspections, partner audits, and quality assessments, including the development and implementation of CAPAs.

• Track KPIs, quality metrics, dashboards, and trend analyses.

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

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

• Propel process optimization, system enhancements, automation, and scalable solutions.

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

⛳️ Requirements

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

• Over 10 years of experience in pharmacovigilance and drug safety operations within the biotechnology and/or pharmaceutical industry.

• Experience in supporting small molecule development programs and/or neuroscience/CNS products in an emerging biotechnology setting is strongly preferred.

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

• Comprehensive 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 similar systems.

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

• Experience in supporting clinical-stage development programs and aggregate safety reporting activities such as DSURs, PBRERs, and Risk Management Plans.

• Demonstrated ability to lead and develop staff, manage competing priorities, and perform effectively in a fast-paced, evolving biotech environment.

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

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

• An advanced degree such as PharmD, MSN, MPH, or MS is preferred.

🏝️ Benefits

• Company bonus based partly on individual and company performance.

• Company-sponsored 401(k).

• Pension plan.

• Vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug benefits.

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

• Life insurance and death benefits.

• Time off and leave of absence benefits.

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

• Remote work opportunities.

• Occasional travel opportunities.