Senior Director, Drug Safety Operations (remote)
About the role
For our client, we are seeking a Senior Director, Drug Safety Operations to join the team of a leader in the Pharmaceuticals & Biotech space. This leader will oversee global drug safety operations and guide the processes that ensure timely, compliant handling of safety information across the organization. The role will partner closely with drug safety leadership, external vendors, and cross-functional stakeholders to strengthen governance, regulatory readiness, and operational performance. This is a highly visible leadership opportunity for someone who can improve pharmacovigilance execution while supporting global business priorities in a regulated biotech environment. The position also calls for a strong operational mindset, with responsibility for vendor oversight, KPI tracking, and continuous improvement across safety workflows. Experience with global pharmacovigilance regulations, safety systems, and GxP compliance will be essential to success.
Responsibilities
- Lead drug safety operations and manage team members to ensure timely and compliant processing of safety information
- Partner with drug safety leadership to enhance operational processes and governance activities
- Execute the global drug safety operations strategy and governance framework to align with business priorities
- Oversee pharmacovigilance operations, including case intake, processing, and regulatory submissions
- Manage relationships with pharmacovigilance vendors and ensure high-quality service delivery
- Continuously improve pharmacovigilance processes and ensure compliance with global regulations
- Monitor operational performance through KPIs and drive continuous improvement initiatives
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or a related field
- 10+ years of experience in pharmacovigilance and drug safety operations in biotech or pharmaceuticals
- Experience with small molecule development and neuroscience/CNS products preferred
- Proven track record managing global safety operations and regulatory submissions in a GxP environment
- Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, and ICH requirements
- Experience overseeing pharmacovigilance vendors and CROs, including compliance and performance management
- Hands-on experience with safety databases and pharmacovigilance technologies
Benefits
- Eligibility for a company-sponsored 401(k) and pension plan
- Vacation benefits and flexible spending accounts for healthcare and dependent care
- Comprehensive medical, dental, vision, and prescription drug benefits
- Life insurance and death benefits
- Well-being benefits including employee assistance programs and fitness benefits
Pay
$160,500 – $259,600 annually
Schedule
Remote — US-based candidates only; no visa sponsorship available