Reporting to the VP, Head of Pharmacovigilance (PV) for the Europe, Middle East, and North Africa (EMENA) region, this highly experienced Pharmacovigilance leader will be responsible for setting the strategy and leading Moderna’s efforts in Pharmacovigilance (PV) in Spain and Portugal. This role will ensure full compliance with all local Spanish and Portuguese PV regulations, will serve as Moderna’s local contact person for pharmacovigilance in Spain and Portugal, and will oversee and manage one or more PV Specialists. This PV leader will work closely with the EU QPPV and with Moderna’s leaders in Regulatory Affairs, Medical Affairs, and Clinical Development as well as other functions in Spain and in the region.
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 to lead our PV efforts in Italy as we launch our COVID-19 vaccine (mRNA 1273) globally to hundreds of millions of patients and experience acceleration in our pipeline and late phase development, thereby poising Moderna for substantial growth in the upcoming years. This role will be a key contributor to and member of the Moderna PV EMENA 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 Spain and Portugal 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 PV requirements, including serving in the role of Moderna’s local contact person for pharmacovigilance in Spain and in Portugal.
Ensuring PV inspection readiness and taking a lead role in ensuring successful local PV inspections, as well as internal PV audits and business partner PV audits – in close partnership with our EU QPPV and with R&D; Quality.
Maintaining robust quality management systems and business continuity plans for PV operations in Spain, Portugal, and in the region.
Closely overseeing all distributors and partners in Spain and Portugal 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 Iberian peninsula and in the region.
Here’s What You’ll Bring to the Table:
- Bachelors 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 Spain.
- Prior experience as a company local contact person for pharmacovigilance for Spain is preferred.
- Previous experience in ICSR case processing, aggregate safety reporting, PV quality management systems, and PV compliance (including supporting local PV inspections)
- Solid knowledge of ICH guidelines relevant to PV and of Spanish, Portuguese, and regional PV regulation and legislation.
- 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)
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit
Moderna is a smoke-free, alcohol-free and drug-free work environment.