Senior Specialist, Pharmacovigilance Operations - Global Quality Standards

Moderna

Warsaw, Poland

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.

In this critical role as a Senior Specialist, PV Operations – Global Quality Standards, you will be responsible for executing key activities related to the initial assessment, processing, and quality control of individual case safety reports (ICSR) from Moderna clinical trials. Your contributions will ensure timely and accurate assessment of adverse event reports, which is crucial for maintaining the highest standards of safety in our clinical operations. You will operate on both the Clinical and Safety databases, proactively managing and requesting information from trial sites and discussing significant adverse events with the Clinical Safety and Risk Management team. Your role will also encompass supporting clinical trial start-up activities, developing and updating essential safety documentation, and collaborating closely with various stakeholders to ensure seamless integration and execution of safety protocols.

Here's What You’ll Do:

Your key responsibilities will be:

Clinical Trial Support: Lead efforts in supporting Moderna clinical trial start-up activities, including the development and continuous update of safety documentation such as the Safety Management Plan (SMP), Safety Reporting Plan (SRP), and SAE Reconciliation Plan. You will provide critical input to the configuration of safety and clinical databases to facilitate effective ICSR processing.
Case Processing and Management: Oversee the triage and quality control of ICSRs, ensuring that each report is reviewed, ranked, verified, and processed in accordance with global regulatory requirements, guidelines, and SOPs. You will craft comprehensive narratives for adverse events and manage the follow-up process with clinical trial sites as needed.
Collaboration and Coordination: Work closely with Global Case Management Leads, Medical Review Physicians, Clinical Safety Scientists, Data Management, and Vendors to ensure the highest level of safety oversight. You may also act as the PV Operations Lead for specific Moderna protocols and contribute to global PV projects.

Your responsibilities will also include:

Training and Mentoring: Collaborate with the Global PV Operations team to create and update training materials, ensuring that case management standards are clearly understood and adhered to. You will mentor new colleagues and assist in training both the Global Case Management team and vendors.
Process Improvement and Compliance: Continuously identify and address gaps in current processes, contributing to the development of improved Global Case Management SOPs. You will support inspection readiness activities and ensure that all procedures comply with regulatory standards.

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

Prioritize the Platform: This role requires a deep understanding of how your contributions fit into the broader mission of Moderna. By focusing on platform-based improvements and ensuring that all safety processes are robust and scalable, you will help drive the success of Moderna's mRNA technology.
Question Convention: As a Senior Specialist, you will be expected to challenge existing norms and continuously seek innovative solutions to complex safety challenges. Your ability to question conventional approaches and propose new methods will be vital in advancing Moderna's commitment to safety and efficacy in clinical trials.

Here’s What You’ll 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).
At least 2-3 years of experience in drug safety/pharmacovigilance case processing.
Proficiency with Argus safety database and other platforms, MS Office suite, Excel, PowerPoint.
Solid knowledge of ICH guidelines relevant to PV and global PV regulations, including FDA, EMA, MHRA, PMDA, and Health Canada.
Experience in clinical trial set-up within PV.
Demonstrated ability to develop, execute, and follow through on complex projects to completion.
Skilled at working effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view.
Independently motivated, detail-oriented, and strong problem-solving ability.
Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities.
Excellent written and verbal communication skills.
Excellent interpersonal skills, ability to develop important relationships with key stakeholders, ability to identify issues and raise to line management in order to develop relevant plans and recommendations.
Fluency in English required.