Specialist, Pharmacovigilance Operations

If youre interested in this role please apply in English and include an English version of your CV.

The Role:

Reporting to the Director PV Operations Case Processing this role will be responsible for effective execution of the activities of triage processing and quality control of individual case safety reports (ICSR) from Moderna clinical trials to ensure timely and accurate assessment of adverse event reports. This role will focus on accurate case entry and writing a detailed narrative to describe adverse events reported in clinical trials. The team in Warsaw Poland will play a critical role in processing all of our pivotal clinical trial cases.

Heres What Youll Do:

• Review rank verify process and document case-related information: event terms; validity seriousness special scenarios; timelines; accuracy and consistency. Process cases based on these assessments
• Use source documents received to write a comprehensive narrative describing the adverse event appropriately
• Process safety data according to applicable regulations guidelines Standard Operating procedures (SOPs) and Company requirements.
• Contribute to the mentoring and training of new colleagues as needed.
• Support continuous improvement opportunities
• Support inspection readiness activities

Heres What Youll Bring to the Table:

• University degree in Pharmacy/Medicine or other relevant life sciences discipline (Dentistry Experimental Medicine Microbiology Veterinary Biotechnology Physiotherapy Medical Biology or similar)
• Minimum 1 year experience in drug safety/pharmacovigilance case processing
• Medical Writing experience preferred
• Argus safety database and other platforms MS Office suite Excel Powerpoint Visio
• Effective time management skills
• Excellent communication skills (verbal and writing); results oriented and strong attention to detail
• Proficiency in English (verbal and/or written) required due to global collaboration needs

Pay & Benefits

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

• Best-in-class healthcare plus voluntary benefit programs to support your unique needs

• A holistic approach to well-being with access to fitness mindfulness and mental health support

• Family building benefits including fertility adoption and surrogacy support

• Generous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary year-end shutdown

• Savingsandinvestments to help you plan for the future

• 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 theinfrastructure 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 peopleare the driving force behind our scientific progress and our 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 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 persons 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.

Were 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 .

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