Associate Director, Aggregate Safety Reporting
Miejsce pracy : Warszawa
Your responsibilities
The Role :
Join Moderna Therapeutics’ enthusiastic and collaborative team and make a significant impact on the overall success of our novel messenger RNA approach to drug development.
Reporting to the Director, Aggregate Safety Reporting, the Associate Director, Aggregate Safety Reporting will be responsible for supporting Moderna’s aggregate reports and other key safety-focused documents for submission to regulatory agencies.
This leader will ensure the highest global standards of quality and compliance with all aggregate safety reporting obligations for all Moderna products throughout the life cycle.
This leader will be instrumental in ensuring the availability of high-quality data for aggregate reports and other key safety-focused documents for submission to regulatory agencies.
This is an exciting time to join Moderna as our COVID-19 vaccine (mRNA 1273) continues to grow globally and we accelerate our pipeline and late phase development efforts, thereby poising Moderna for substantial growth in the upcoming years.
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 :
Responsible for delivery of aggregate safety reports (ASRs) and support delivery of risk management plan (RMP) documents for investigational and marketed products
Support the authoring and editing of periodic aggregate safety reports, including but not limited to PBRER / PSUR, PADER, DSUR, and IND annual reports in collaboration with Clinical Safety and Risk Management (CSRM) physicians, safety scientists, medical colleagues, and PV Project Management.
Assist in authoring, writing and editing RMPs in collaboration with Clinical Safety and Risk Management (CSRM), physicians, safety scientists, and medical colleagues
Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues
Review applicable regulatory intelligence on global regulations / guidance documents and be able to advise report project teams as a Subject Matter Expert (SME) for aggregate safety reports
Oversee compliance, quality, procedures, regulations, timeliness, and consistency of scheduled and unscheduled aggregate reports.
Understand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and other reports and / or deliverables
Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission
Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents
Participates in cross-functional teams to create new policies to develop and promote best practices, processes, identify new tools, and develop new policies to promote consistent aggregate reports excellence, ensure safe and appropriate use of our products and monitor performance trends and drive continue process improvements related to aggregate reports
Produce high quality, accurate, and fit-for-purpose evaluation documents with clear conclusions, in response to internal or regulatory authority request for safety reasons
Review the worldwide medical / scientific literature to identify signals and applicable information for inclusion in aggregate safety reports in collaboration with CSRM colleagues
Draft regulatory response documents such as PRAC assessment reports
Draft other medical writing deliverables as needed
Management of vendor activities related to aggregate reports including responsibility for quality and compliance with SOPs for the vendor staff
Support PV Operations, PV audits and inspections
Our requirements
Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background
Minimum of 8 years relevant medical, scientific / clinical, or pharmaceutical experience, including at least 5 years’ experience in Pharmacovigilance
Excellent written and verbal communication skills with the ability to interpret and present safety data and interact across multiple functions
Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process
Ability to manage / lead in a matrix environment
Knowledge of drug safety / pharmacovigilance practices and tools
Ability to coordinate and prioritize multiple projects in a fast-paced environment with limited to little supervision
Background in vaccines is a plus
Demonstrated ability to develop, execute and follow-through complex projects to completion
Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
Independently motivated, detail oriented and strong problem-solving ability with strong scientific, analytical and conceptual skills
Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities
Proficiency in Microsoft Word, Excel, and PowerPoint
Benefits
private medical care
employee referral program
extra leave
generous computer glasses and contact lens reimbursement
equity plan
well-being programs
1 month paid sabbatical after 5 years
MODERNA MISSION :
Why we come to work every day?
MODERNA MISSION
Deliver on the promise of MRNA science to create a new generation of transformative medicines for patients.
About MIBS :
The brand new Moderna International Business Center is an exciting next step in our global expansion. Based in the heart of Warsaw, it provides our growing organization with innovative and strategic support to help scale our business for the benefit of people and patients around the world.
We offer an opportunities in Digital, Finance, Human Resources, Pharmacovigilance and Supply Chain.
Moderna Poland
Welcome to Moderna. We believe mRNA is the software of life."
Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease.
Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching and could meaningfully improve how medicines are discovered, developed and manufactured.
Since our founding in 2010, we have worked to build the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and early development, a rapidly expanding pipeline, and a world-class team.
Our pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials underway with other development candidates progressing toward the clinic.
In addition, we have numerous discovery programs advancing toward development.
