Senior Director, Pharmacovigilance Operations

This is a fully remote position, open to applicants in Poland, +5 more countries.

📋 Description

• Direct the strategic formulation and operational management of the global Central Pharmacovigilance Services organization.

• Implement the Central PV Services strategy in accordance with the objectives of the PV & MI Business Unit.

• Create scalable centralized PV operating frameworks for global clinical development and post-marketing initiatives.

• Establish, enhance, and optimize global PV service hubs.

• Develop strategic outsourcing frameworks and promote operational excellence, automation, AI-driven technologies, and digital transformation.

• Provide counsel to the VP, Global Safety & MI regarding operational strategy, service delivery, capacity planning, and operational risks.

• Supervise ICSR processing, literature monitoring, signal detection and management, benefit-risk assessment, aggregate safety reporting, and other related PV services.

• Ensure compliance with regulations, contractual obligations, internal protocols, quality standards, and client expectations.

• Track operational, quality, and productivity KPIs; handle escalations, corrective actions, and continual improvement efforts.

• Assist in regulatory inspections and client audits; oversee CAPAs and compliance oversight.

• Contribute to financial objectives, pricing strategies, proposals, RFIs, RFPs, and bid defenses.

• Lead and nurture the Central PV Services leadership team, focusing on 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 discussions, operational evaluations, and client interactions.

• Identify areas for improvement, suggest solutions, act as a deputy for department staff as needed, and carry out additional assigned responsibilities.

⛳️ Requirements

• MD, PharmD, PhD, MSc, or an equivalent scientific degree is preferred.

• Minimum of 12 years of experience in pharmacovigilance.

• At least 5 years of progressive leadership experience in managing global PV operations.

• Proven experience in leading centralized PV services and global delivery teams.

• Extensive understanding of case processing, literature monitoring, signal detection, benefit-risk management, and aggregate reporting.

• Experience in establishing global shared service centers and scalable outsourcing frameworks.

• Strong knowledge of EU GVP Modules, ICH guidelines, FDA, and global PV regulations.

• Experience in supporting regulatory inspections and client audits.

• Strong familiarity with safety databases and PV technologies.

• Exhibit strong leadership and collaboration skills by effectively guiding and aligning global operational teams.

• Promote executive communication through operational excellence and strategic implementation.

• Influence stakeholders across complex global organizations.

• Demonstrate strategic thinking combined with a focus on operational excellence.

• Utilize advanced decision-making and problem-solving abilities.

• Display negotiation skills and commercial insight with a client-centric approach.

• Keep abreast of emerging PV technologies, automation, AI, and regulatory changes.

• Adapt effectively to and lead organizational transformations.

• Employ coaching and mentoring methodologies to cultivate future leaders.

• Exhibit behaviors consistent with Company values, cultural sensitivity, and the ability to function effectively in diverse settings.

• Proficient in English, both spoken and written, at a professional level.

🏝️ Benefits

• International team and environment.

• Remote work, workation options, and flexibility.

• Health and wellbeing initiatives.

• Opportunities for professional growth and development in the life sciences sector.

• Team culture initiatives, including team building, global meetings, and B Active events.

• Performance-based annual bonuses.

• Comprehensive insurance coverage, including personal accident, business travel, and additional health insurance.