Director, PV Country Head, Poland & Eastern Europe
Director, PV Country Head, Poland & Eastern Europe
Moderna
Warsaw, Poland
The Role:
Reporting to the VP, Head of Pharmacovigilance (PV) for the Europe, Middle East and Africa (EMEA) region, this highly experienced Pharmacovigilance leader will be responsible for setting the strategy and leading Moderna’s efforts in Pharmacovigilance (PV) for the Eastern European region. This role will ensure full compliance with all local PV regulations in the region and may oversee and manage one or more PV Specialists. This PV leader will work closely with the EEA QPPV and with Moderna’s leaders in Regulatory Affairs, Medical Affairs, and Clinical Development as well as other functions locally and regionally. This position will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally. This is an exciting time to join Moderna as our COVID-19 vaccine (mRNA 1273) continues to grow globally and we accelerate our pipeline and late phase development efforts, thereby poising Moderna for substantial growth in the upcoming years. This role will be a key contributor to and member of the Moderna PV EMEA leadership team and will have the opportunity to make critical contributions to Moderna’s future success in making a transformative impact to patients through our vaccines and therapeutics using our mRNA platform.
Here’s What You’ll Do:
- Provide dynamic leadership, strategic direction and close oversight of all pharmacovigilance activities in the Eastern European region across Moderna’s portfolio and throughout the clinical development and post-marketing phases of the life cycle including:
- Ensuring local and regional compliance with ICSR and aggregate safety reporting obligations;
- Fulfilling all additional local regulatory authority PV requirements in close partnership with the EU QPPV;
- Ensuring PV inspection readiness and taking a lead role in ensuring successful PV inspections, as well as internal PV audits and business partner PV audits – in close partnership with our CSPV Compliance function, EU QPPV and R&D Quality Assurance;
- Maintaining robust quality management systems and business continuity plans for PV operations in the region;
- Closely overseeing all distributors and partners in the region who perform PV activities on behalf of Moderna;
- Engaging externally to ensure ongoing benchmarking and the leveraging of best practices;
- Supporting the implementation of additional risk minimization measures and of safety label updates in the Nordic region.
Here’s What You’ll Bring to the Table:
- Bachelor's degree (preferably in a science or health related field) and a minimum of 10 years of experience in Pharmacovigilance Operations and/or local or regional PV roles the biopharmaceutical industry, with at least 5 years of PV experience in the applicable region;
- Previous experience in ICSR case processing, aggregate safety reporting, PV quality management systems, and PV compliance (including supporting inspections);
- Solid knowledge of ICH guidelines relevant to PV and of PV regulation and legislation in the Eastern European region;
- Strong managerial skills across countries and ability to partner closely and effectively cross-functionally;
- Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes;
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations;
- Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks while working in a matrixed environment;
- Ability to manage multiple projects in a fast-paced environment;
- Ability to combine pharmacovigilance expertise with exceptional leadership (strategic thinking, people and resource management).
