[Hiring] (Senior) Director Pharmacovigilance Operations @Biomapas

Role Description

(Senior) Director Pharmacovigilance Operations/Central PV Services is responsible for the leadership, strategic development, and operational oversight of the global Central Pharmacovigilance (PV) Services organization. The role ensures compliant, efficient, and scalable delivery of centralized pharmacovigilance services, including:

• Individual Case Safety Report (ICSR) processing
• Literature surveillance
• Signal detection and management
• Benefit-risk management
• Aggregate safety reporting
• Related PV operational services

The role is accountable for building and expanding strategic global delivery hubs, developing scalable outsourcing models, driving operational excellence, and supporting the operational, financial, and client objectives of the PV & MI Business Unit.

Qualifications

• 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.

Requirements

• Execute the Central PV Services strategy in alignment with the PV & MI Business Unit objectives.
• Develop scalable centralized PV operating models supporting global clinical development and post-marketing programs.
• Lead establishment, expansion, and optimization of global PV delivery hubs.
• Develop strategic outsourcing models to improve scalability, quality, operational efficiency, and financial performance.
• Drive innovation, automation, AI-enabled technologies, and digital transformation across Central PV Services.
• Advise the VP, Global Safety & MI on operational strategy, service delivery, capacity planning, and operational risks.
• Act as escalation point for significant Central PV operational and service delivery issues.
• Provide operational performance reporting, delivery metrics, and strategic updates to senior management.
• Ensure all Central PV Services are delivered in accordance with applicable regulations, contractual obligations, internal procedures, quality standards, and client expectations.
• Monitor operational, quality, and productivity KPIs, ensuring timely escalation, corrective actions, and continuous improvement initiatives.
• Drive operational excellence through standardized processes, technology enablement, automation, and scalable delivery models that support sustainable business growth.

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.