Senior Director, Pharmacovigilance Operations
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Job Description
Senior Director leading global pharmacovigilance operations for a life science company. Overseeing centralized PV delivery, regulatory compliance, delivery hubs, outsourcing, and strategic client support.
Responsibilities:
- Lead the strategic development and operational oversight of the global Central Pharmacovigilance Services organization.
- Execute the Central PV Services strategy in alignment with PV & MI Business Unit objectives.
- Develop scalable centralized PV operating models for global clinical development and post-marketing programs.
- Establish, expand and optimize global PV delivery hubs.
- Develop strategic outsourcing models and drive operational excellence, automation, AI-enabled technologies and digital transformation.
- Advise the VP, Global Safety & MI on operational strategy, service delivery, capacity planning and operational risks.
- Oversee ICSR processing, literature surveillance, signal detection and management, benefit-risk management, aggregate safety reporting, and related PV services.
- Ensure services comply with regulations, contractual obligations, internal procedures, quality standards and client expectations.
- Monitor operational, quality and productivity KPIs; manage escalations, corrective actions and continuous improvement.
- Support regulatory inspections and client audits; oversee CAPAs and compliance monitoring.
- Contribute to financial targets, pricing, proposals, RFIs, RFPs and bid defenses.
- Lead and develop the Central PV Services leadership team, including succession planning and talent development.
- Collaborate with QPPV Office, Medical/Clinical Safety, PV/MI Technologies, Medical Information, Quality, Regulatory, Commercial, Legal and Business Development.
- Represent Central PV Services in governance meetings, operational reviews and client engagements.
- Identify improvements, propose solutions, deputize for department staff as instructed, and perform additional assigned tasks.
Requirements:
- MD, PharmD, PhD, MSc or equivalent scientific degree preferred.
- At least 12 years of pharmacovigilance experience.
- At least 5 years of progressive leadership experience managing global PV operations.
- Demonstrated experience leading centralized PV services and global delivery organizations.
- Extensive knowledge of case processing, literature surveillance, signal detection, benefit-risk management and aggregate reporting.
- Experience building global shared service centers and scalable outsourcing models.
- Strong knowledge of EU GVP Modules, ICH guidelines, FDA and global PV regulations.
- Experience supporting regulatory inspections and client audits.
- Strong understanding of safety databases and PV technologies.
- Demonstrate strong leadership and collaboration by effectively leading and aligning global operational teams.
- Drive executive communication through operational excellence and strategic execution.
- Influence stakeholders across complex global organizations.
- Demonstrate strategic thinking with a strong operational excellence mindset.
- Apply advanced decision-making and problem-solving skills.
- Demonstrate negotiation skills and commercial acumen with a client-focused approach.
- Stay informed of emerging PV technologies, automation, AI, and regulatory developments.
- Effectively adapt to and lead organizational change.
- Apply coaching and mentoring techniques to develop future leaders.
- Demonstrate behaviors aligned with Company values, cultural awareness, and the ability to work effectively in diverse environments.
- Professional level in English, both oral and written.
Benefits:
- International team and environment
- Remote Work, workation & Flexibility
- Health & Wellbeing – wellness initiatives
- Professional growth and development in the Life science industry
- Team Culture – Team buildings, global meetings, and B Active events.
- Performance based annual bonus
- Comprehensive Insurance - Personal accident, business trip coverage, and additional health insurance.
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