Job Description

Role Summary

The Senior Director, Pharmacovigilance Sciences provides strategic leadership and scientific oversight for safety data analysis across both investigational and marketed products. This role leads a high-performing PV Sciences team responsible for core safety surveillance activities, regulatory safety deliverables, and cross-functional safety support throughout the product lifecycle.

The ideal candidate excels both independently and collaboratively and brings deep expertise in safety science, signal management, regulatory documentation, and team leadership.

Key Responsibilities

Portfolio Safety Leadership

• Oversee all PV Sciences deliverables across the companys development and commercial portfolio.
• Ensure compliance and scientific rigor across the full spectrum of PV Sciences activities, including:
• Signal detection, evaluation, and management
• Preparation and review of aggregate reports (e.g., DSURs, PADERs, PBRERs)
• Development and maintenance of Risk Management Plans, including risk minimization measures
• Ongoing literature surveillance
• Safety governance meeting preparation, documentation, and follow-up
• Responses to safety-related regulatory queries
• Safety contributions to core documents (IB/RSIs, CCDS/labels, ICFs, etc.)
• Safety analyses for major regulatory filings (e.g., NDA, MAA)
• Preparation for and participation in audits and inspections

Strategic Leadership & Team Management

• Define strategic direction for the PV Sciences function, aligning with organizational goals and evolving safety priorities.
• Lead, mentor, and develop a team of PV Scientists, fostering scientific excellence and professional growth.
• Drive talent recruitment, workforce planning, and performance management.
• Collaborate closely with Clinical Development, Regulatory Affairs, Quality, Medical Affairs, and other stakeholders to ensure integrated and proactive safety oversight.
• Lead process and systems improvements, including conducting impact assessments and driving innovation within safety science.
• Ensure adequate training and ongoing professional development for direct and indirect reports.
• Contribute to additional cross-functional initiatives as required.

Qualifications

Required

• PhD or equivalent with 10+ years of pharmacovigilance experience; OR Bachelors/Masters with 15+ years of experience in a PV Scientist role.
• Demonstrated expertise in medical and scientific data evaluation across both clinical trials and post-marketing settings.
• Exceptional verbal and written communication skills, including the ability to present to and influence senior leadership.
• Strong critical-thinking skills with meticulous attention to detail and the ability to prioritize effectively.
• Advanced knowledge of global pharmacovigilance regulations, drug development processes, and safety reporting requirements.
• Proven experience preparing and reviewing regulatory safety documentation, including NDAs/MAAs and Risk Management Plans.
• Experience serving as a subject matter expert during audits and inspections.

Preferred

• Experience in oncology therapeutic areas.
• Proficiency with PV databases and coding dictionaries (e.g., MedDRA).
• Advanced skills with Microsoft Office and safety systems such as Argus.

Benefits

• Competitive compensation package and annual bonus opportunity.
• Comprehensive benefits including medical, dental, and vision coverage; retirement plan with employer match; and additional wellness offerings.
• Generous parental leave and family planning benefits.
• A collaborative culture with strong support for personal and professional development.

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