Safety Aggregate Report Manager

Project role : Safety Aggregate Report Manager

Work experience : 8+ years.

Work location : Bangalore - Homebased.

Must have skills : Team Lead, Mentoring Experience

Job overview :

Act as a stand-alone global functional lead at a project level applying experience, knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including but not limited to safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project / client initiatives. Ensure team is following standard best-in-class practices established by the SARA infrastructure.

Essential Functions

• Serve as a stand-alone global lead for aggregate reporting, signal management, or literature surveillance projects.
• Lead, author and finalize aggregate reports, including but not limited to PBRERs / PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings and author responses to regulatory agency / Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
• Act as literature lead, back-up lead, reviewer / QCers to conduct ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data & / or signal detection relevance review. Author and / or contribute to literature deliverables for aggregate reports & / or signal management activities meeting strict regulatory timelines.

Act as Signal Management Lead on large and / or complex post-marketing and clinical trial projects. Set up, implement, organize (including documentation) and lead safety management teams. Serve as subject matter expert across projects for complex data mining methodogies and algorithms on internal and external safety datasources. Oversee / set-up and update products' signaling strategies. Oversee / author and / or QC review all types of signal management deliverables.

Act as mentor to and coach to project team staff and direct line reports.

Review project files and contact lists on a regular basis to ensure compliance with SOPs

Qualifications