Associate Director, Medical Safety Review Physician

The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.

As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.

Moderna is solidifying its presence within our international business services hub in Warsaw, Poland, a city renowned for its rich scientific and technological heritage. This hub provides critical functions, meeting the growing demand of Moderna’s global business operations. We're inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.

As a key member of the Clinical Safety and Risk Management group, the Medical Safety Review Physician will play a critical role in ensuring patient safety across Moderna’s global mRNA portfolio. This role will focus on the clinical assessment and regulatory evaluation of individual case safety reports (ICSRs) and aggregated safety data from both clinical trials and post-marketing settings. The successful candidate will bring clinical expertise, pharmacovigilance acumen, and strong cross-functional collaboration to oversee external vendors, evaluate causality, and maintain medical accuracy across Moderna's expanding pipeline. Reporting to the Director, Lead Medical Safety Review Physician, this Warsaw-based individual contributor position will be instrumental in establishing and elevating Moderna’s in-house medical review function as the company scales globally. The role offers the opportunity to shape global pharmacovigilance strategy, drive excellence in medical review, and engage closely with Generative AI-powered tools to support safety signal detection and regulatory readiness.

Here'S What You’Ll Do:

Your Key Responsibilities Will Be:

• Perform timely medical review of ICSRs (clinical trial and post-marketing) including causality assessment, seriousness, and expectedness determinations.
• Ensure completeness, accuracy, and regulatory compliance in AE case processing by applying appropriate medical interpretation and global standards.
• Oversee and guide external vendors and CROs performing outsourced medical review, ensuring consistency and quality.
• Provide cross-functional support to safety-related regulatory submissions (e.g., BLA) and ad hoc data reviews.

Your Responsibilities Will Also Include:

• Serve as a global medical safety point of contact for ICSR-related medical issues and coding accuracy.
• Guide vendor medical reviewers and collaborate with PV Ops ICSR Quality and Analytics to monitor performance and compliance.
• Ensure timely identification and communication of adverse events of special interest and emerging safety signals.
• Participate in signal detection, aggregate data review, and ongoing safety analysis in alignment with product/program safety leads.
• Actively support audits and inspections, offering insights into vendor oversight and medical review systems.
• Collaborate closely with product physicians/medical monitors to ensure aligned safety strategy.
• Leverage advanced safety tools and digital technologies, including emerging Generative AI solutions, to enhance efficiency and analytical depth.

The key Moderna Mindsets you’ll need to succeed in the role:

• We behave like owners. The solutions we’re building go beyond any job description.
• This role requires taking ownership of Moderna's global pharmacovigilance standards by not only executing medical reviews but driving vendor oversight and strategic consistency across programs.
• We digitize everywhere possible using the power of code to maximize our impact on patients.
• You will have opportunities to partner with cross-functional teams to explore digital innovations, including AI-driven analytics, to optimize case review processes and safety signal detection.

Here’s What You’ll Bring to the Table:

• MD or international equivalent required
• Clinical experience, minimum of 3 years’ experience in a drug safety surveillance setting within the pharmaceutical/biopharmaceutical industry; with both clinical and post-marketing experience in a multi-disciplinary team matrix model – or comparable relevant experience.
• Strong written, spoken and presentation communication skills

• Proven Ability To:

• Deliver high-quality results within established timelines
• Utilize technology supporting pharmacovigilance
• Integrate concepts and guidelines from FDA, EMA, PMDA and other regulatory agencies, public health agencies, nongovernmental organizations, and clinical practice groups
• Support establishment of standards, procedures, and process elements for medical review
• Thrive in a fast-paced environment while providing appropriate attention to detail
• Excellent analytical, problem-solving, strategic planning, and interpersonal skills.
• Moderna seeks candidates aligned with its culture centered on bold, collaborative, curious, and relentless values which enable innovation in mRNA-based vaccines and therapeutics to benefit patients.

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments
• Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.  

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. 

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. 

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. 

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. 

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

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! 

Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com. 

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