The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.
Essential Job Duties and Responsibilities
The Senior Aggregate Report Scientist (ARS) will support the scheduled post-marketing aggregate report deliverables and work in close collaboration with other partners to collect, interpret, and incorporate data from a variety of sources into the reports to properly communicate the benefit-risk of the product.
The Senior ARS will have basic knowledge of the industry regulations and guidance for scheduled aggregate reports and a broad understanding of content needed for the reports.
The Senior ARS will serve as product point of contact and lead cross-functional teams in producing scheduled aggregate reports, providing guidance on content, processes, timelines, and scientific integrity to ensure well-written reports.
The Senior ARS will function independently, link discussions to content, and deliver quality results with some guidance/support from more senior ARS. Senior ARS will build alliances and be able to influence safety partners to shape decisions/outcomes.
The Senior ARS will be responsible for aggregate report preparation including:
- Developing knowledge of pharmacovigilance (PV) regulations and purpose of the scheduled aggregate reports.
- Effectively partnering with stakeholders (e.g., Global Medical Safety (GMS) staff, vendor, regulatory) and leading the production of the scheduled aggregate report to ensure high quality safety reports and to optimize data retrieval.
- Ensuring Health Authority (HA) requests/Assessment Reports have been addressed as required in scheduled aggregate reports.
- Reviewing and/or writing safety topics for scheduled aggregate reports for applicable products (e.g., Established Products).
- Interpreting and integrating information in a clear, concise manner.
- Developing conclusions based on all information for applicable products.
Participate in cross-functional training of relevant stakeholders and contribute to training of ARS on activities within the role.
Participate in department and/or cross-functional initiatives.
- Bachelor’s Degree Required: Healthcare-related or Biomedical Science (4+ years industry experience or equivalent).
- Advanced Degree Preferred: Healthcare-related or Biomedical Science (2+ years industry experience or equivalent).
- Medical writing or PV experience required.
- Knowledge of global regulatory framework for aggregate safety reports & experience in developing aggregate safety reports [e.g., Periodic Benefit-Risk Evaluation Report (PBRER)].
- Clinical experience preferred.
- Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements.
- Ability to understand and analyze complex medical-scientific data from a broad range of disciplines.
- Ability to interpret and present complex data to determine benefit-risk impact.
- Excellent English verbal and written communication skills.
- Ability to effectively interact with stakeholders, including business partners.
- Ability to work in a matrix environment, proven leadership skills.
- Ability to plan work to meet deadlines and effectively handle multiple priorities.
- Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint).
- Ability to influence, negotiate and communicate with both internal and external customers.
Hybrid mode (3 days working from the office and 2 days working from home).