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Biomapas

(Senior) Director Pharmacovigilance Operations

LocationHungary
Work moderemote
Typefull-time
DepartmentPV/RA/MI Operations
Company size1+ people
First seen1w ago
Last seen3d ago
About the role
(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, and 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.
Key areas of responsibility and main tasks:
Strategic & Functional Leadership
•
Execute the Central PV Services strategy in alignment with the PV & MI Business Unit objectives.
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Develop scalable centralized PV operating models supporting global clinical development and post-marketing programs.
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Lead establishment, expansion and optimization of global PV delivery hubs.
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Develop strategic outsourcing models to improve scalability, quality, operational efficiency, and financial performance.
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Drive innovation, automation, AI-enabled technologies and digital transformation across Central PV Services.
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Advise the VP, Global Safety & MI on operational strategy, service delivery, capacity planning and operational risks.
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Act as escalation point for significant Central PV operational and service delivery issues.
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Provide operational performance reporting, delivery metrics and strategic updates to senior management.
Central PV Operations & Delivery Excellence
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Provide strategic and operational oversight of centralized pharmacovigilance services across:
1.
Case Management (ICSR processing, case intake and triage, medical coding, quality review, and medical review support).
2.
Literature Management (literature surveillance, screening, and literature case processing).
3.
Signal & Benefit-Risk Management (signal detection, validation, evaluation, benefit-risk assessment, and related risk management activities).
4.
Aggregate Safety Reporting (PSURs/PBRERs, DSURs, PADERs, and other regulatory aggregate safety reports).
5.
Operational Excellence (Safety Data Exchange activities, operational metrics and reporting, process standardization, automation, continuous improvement, and service delivery governance).
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Ensure all Central PV Services are delivered in accordance with applicable regulations, contractual obligations, internal procedures, quality standards, and client expectations.
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Monitor operational, quality, and productivity KPIs, ensuring timely escalation, corrective actions, and continuous improvement initiatives.
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Drive operational excellence through standardized processes, technology enablement, automation, and scalable delivery models that support sustainable business growth.
Global Delivery Hub & Outsourcing Strategy
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Develop and implement the global strategy for centralized PV delivery, ensuring scalable, efficient, and consistent service delivery across regions.
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Build, expand, and optimize strategic centralized PV delivery hubs to support business growth and evolving client needs.
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Lead the transition and integration of PV activities into centralized delivery models, ensuring effective governance, business continuity, and operational consistency.
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Establish standardized operating models, resource planning, and workforce strategies to optimize capacity, utilization, and delivery performance across global operations.
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Drive continuous improvement through process optimization, innovation, digital solutions, and enabling technologies to enhance quality, efficiency, and scalability.
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Develop and maintain resilient global delivery capabilities that support sustainable growth, client satisfaction, and high-quality service delivery.
Compliance & Operational Quality
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Maintain inspection-ready Central PV operational processes.
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Ensure delivery complies with EU GVP Modules, FDA, ICH and other applicable global regulations.
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Support regulatory inspections and client audits involving Central PV Services.
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Oversee implementation and follow-up of CAPAs related to operational activities.
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Ensure governance of operational KPIs, quality metrics and compliance monitoring.
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Collaborate with QPPV Office, Medical/Clinical Safety, PV/MI Technologies, and Medical Information functions to ensure harmonized PV/MI governance.
Financial & Business Support
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Contribute to Business Unit financial targets through effective operational planning, workforce optimization and resource forecasting.
•
Support pricing, proposals, RFIs, RFPs and bid defenses by providing operational expertise, delivery models and resource assumptions.
•
Identify opportunities for operational efficiencies, automation and cost optimization while maintaining quality and compliance.
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Support expansion of Central PV Services across existing and new clients.
Team Management
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Lead and develop the Central PV Services leadership team.
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Build organizational capability supporting global service expansion.
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Drive succession planning and talent development.
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Promote a culture of operational excellence, accountability, innovation and continuous improvement.
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Ensure appropriate organizational structures supporting sustainable growth.
Client & Cross-Functional Collaboration
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Support client retention through high-quality operational delivery and continuous service improvement.
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Partner closely with the QPPV Office, Program Management, Operations Strategy, PV/MI Technologies, Medical & Clinical Safety and Medical Information to ensure integrated service delivery.
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Collaborate with Quality, Regulatory, Commercial, Legal and Business Development functions.
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Represent Central PV Services during governance meetings, operational reviews and client engagements.
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Support strategic client initiatives involving centralized PV outsourcing and transformation
Other responsibilities
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Identify areas for improvement and proactively propose solutions within the area of responsibility.
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Deputize for another employee or staff member of the same department as instructed by the Head of Department.
Perform additional tasks related to the department’s activities as assigned by the Head of Department
Requirements
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MD, PharmD, PhD, MSc or equivalent scientific degree preferred.
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At least 12 years of pharmacovigilance experience.
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At least 5 years of progressive leadership experience managing global PV operations.
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Demonstrated experience leading centralized PV services and global delivery organizations.
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Extensive knowledge of case processing, literature surveillance, signal detection, benefit-risk management and aggregate reporting.
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Experience building global shared service centers and scalable outsourcing models.
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Strong knowledge of EU GVP Modules, ICH guidelines, FDA and global PV regulations.
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Experience supporting regulatory inspections and client audits.
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Strong understanding of safety databases and PV technologies.
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Demonstrate strong leadership and collaboration by effectively leading and aligning global operational teams.
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Drive executive communication through operational excellence and strategic execution.
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Influence stakeholders across complex global organizations.
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Demonstrate strategic thinking with a strong operational excellence mindset.
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Apply advanced decision-making and problem-solving skills.
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Demonstrate negotiation skills and commercial acumen with a client-focused approach.
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Stay informed of emerging PV technologies, automation, AI, and regulatory developments.
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Effectively adapt to and lead organizational change.
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Apply coaching and mentoring techniques to develop future leaders.
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Demonstrate behaviors aligned with Company values, cultural awareness, and the ability to work effectively in diverse environments.
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Professional level in English, both oral and written.
Benefits
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International team and environment
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Remote Work, workation & Flexibility
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Health & Wellbeing – wellness initiatives
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Professional growth and development in the Life science industry
•
Team Culture – Team buildings, global meetings, and B Active events.
•
Performance based annual bonus
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Comprehensive Insurance - Personal accident, business trip coverage, and additional health insurance.
More roles at Biomapas
Medical Information and Pharmacovigilance Specialist (Nordics)Clinical Research Associate (CRA) UkrainePharmacovigilance Specialist DACH regionSenior Pharmacovigilance SpecialistRegulatory Affairs Specialist Ukraine
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