Senior Director, Pharmacovigilance Operations

🔥 12 hours ago

🌐 Poland, Spain, +4 more countries – Remote

🇵🇱 Poland – Remote 🇪🇸 Spain – Remote 🇬🇷 Greece – Remote 🇷🇴 Romania – Remote 🇧🇬 Bulgaria – Remote 🇭🇺 Hungary – Remote

⏰ Full Time

🟠 Senior

⚙️ Operations

👻 Ghost score 10%

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Biomapas

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Biomapas is a comprehensive outsourcing solution provider catering to the global life science sector. The company acts as a strategic partner for biopharmaceutical and medical device companies, offering extensive clinical research services worldwide. Biomapas covers the entire product lifecycle from regulatory compliance to pharmacovigilance and medical information. The company operates across various regions including Europe, CIS, EAEU, MENA, LATAM, and the US, ensuring high-quality, efficient, and cost-effective methodologies to deliver superior service and strategic advantages. With a focus on clinical trials, pharmacovigilance, and regulatory affairs, Biomapas is equipped to navigate complex regulatory environments and manage clinical trial data effectively, contributing to clients' commercial success.

📋 Description

• 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.