Director, Country Head, Pharmacovigilance – Canada

The Role:
Reporting to the Pharmacovigilance Head for Rest of World (ROW) in the role PV Country Lead for Moderna’s subsidiary in Canada this highly experienced Pharmacovigilance leader will be responsible for setting the strategy and leading Moderna’s efforts in Pharmacovigilance (PV) in Canada. This role will ensure full compliance with all Health Canada regulations. This PV leader will work closely and cross-functionally with other leaders at Moderna Canada as well as globally with other Clinical Safety and PV leaders to ensure global alignment as well as local compliance. This position will have a high degree of visibility and impact and will continuously and effectively collaborate cross-functionally and cross-regionally. This is an exciting time to join Moderna to build and establish an industry-leading PV team in Canada 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 and a key senior PV leader overseeing all of our Clinical Safety and PV efforts in support of ensuring patient safety for Canadian patients who receive Moderna’s experimental and authorized products. In addition, this role 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 Canada across Moderna’s portfolio and throughout the clinical development and post-marketing phases of the life cycle including:

Ensuring local Canada compliance with ICSR and aggregate safety reporting obligations and with global reporting obligations for cases originating from Canada

Fulfilling all additional local regulatory PV requirements.

Ensuring PV inspection readiness and taking a lead role in ensuring successful Health Canada PV inspections, internal PV audits, and business partner PV audits.

Maintaining robust quality management systems and business continuing plans for PV operations in Canada.

Closely overseeing all vendors and partners in Canada 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 Canada and proactively training all Moderna staff regarding AE reporting and other PV obligations.

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, with at least 5 years of experience in Pharmacovigilance in Canada. Must have prior successful managerial experience.

Prior experience in ICSR case processing, aggregate safety reporting, PV quality management systems, and PV compliance (including Health Canada PV inspections).

Solid knowledge of Health Canada regulations and related province regulations

Significant experience working with CROs, vendors, and relationship management.

Strong managerial skills and ability to partner closely and effectively cross-functionally and cross-regionally.

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)

About Moderna :
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 www.modernatx.com .

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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