Safety Aggregate Reporting Manager

Designation : Safety Aggregate Reporting Manager

Skill: Authoring Aggregate reports

Experience: 7+

Location : Across PAN India

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

• Serve as a stand-alone global lead for aggregate reporting, signal management.

• 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.
• Oversee/conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Accountable for full documentation and tracking of signals. At project level, maintain compliance, prepare metrics and KPI, present at audits and inspections.
• In a PV support role, act as functional lead and oversee/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
• Provide training to SARA staff for qualification on SARA deliverables
• May perform quality check of all assigned SARA deliverables
• be responsible for the quality of the final SARA deliverable to client regulatory, IQVIA regulatory reporting (RR), and regulatory authorties.
• Provide consultative guidance to internal and external stakeholders in the for all SARA deliverables.
• Act as mentor to and coach to project team staff and direct line reports.

Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP),