Safety Aggreg Reporting

1 week ago


Bengaluru, Karnataka, India Zaportiv Full time

Job Title:
Safety Aggreg Reporting
Total Experience: 3 -6 years
Relevant Experience: 3+ yearsLocation: Bangalore

Notice Period:
Immediate

Roles and ResponsibilitiesJob Profile SummaryTitleBill RateExpSafety Aggreg Report Spec1-3 LPA3-4 yrs Pharmacovigilance 0-2 yrs Aggregate ReportingSafety Aggreg Report Spec2-5 LPA4-6 yrs Pharmacovigilance 2-4 yrs Aggregate ReportingSafety Aggreg Report Mgr8 LPA6+ yrs Pharmacovigilance 4+ yrs Aggregate Reporting

Apply knowledge and expertise for Safety Aggregate Report and Analytics(SARA) Centre deliverables including safety aggregate reports, literaturesurveillance, signal management activities and benefit-risk managementdocuments


Roles and ResponsibilitiesServe as principal owner of the SARA deliverable and have responsibility for the completion of the deliverable in compliance with all applicable service level agreements (SLA).Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.

Conduct/Lead 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 review.

Act as Signal Management Lead on post-marketing and clinical trial projects. Set up, implement, organize (including documentation), and lead safety management teams. Set up and update products' signalling strategies. The author and/or QC review all types of signal management deliverables.

Lead/ conduct ongoing signal detection activities as per agreed signalling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterization of risks.

Responsible for full documentation and tracking of signals.

In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.

Interface with clients and other functional groups within Lifecycle Safety and other business units, such asRegulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing,Clinical Research, Quality,Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.

Participate in internal and external audits and inspections, as required.

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