Job Code

JD-20559

JOB DESCRIPTION

literature surveillance,signal management,Signal Management Lead,Library Information Services

Experience Required

4 - 10 Years

Industry Type

IT

Employment Type

Permanent

Location

India

Roles & Responsibilities

Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs,,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,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,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), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) /,Participate in internal and external audits and inspections, as required