IQVIA Released Job Openings On 16/12/2022.The Company offers commercial, physical, and biological research and development services, as well as value-based analyses, research studies, clinical management analytics, and health outcome optimization services.Application form link provided at the end of post. Eligibility for the Clinical Informatics as follows.
Vacancy Details:
IQVIA Recruiting B.Pharama,M.Pharma,Pharm.D,BDS,MDS,BAMS & BHMS with 08-12 Years Experience for For Safety Aggregate Reporting Manager position.
Important Details :
- Location : Hybrid
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: NA
- Opening date for online Application:16/12/2022
- Mode of application :Online
- How To Apply: Candidates who are interested can please revert with your updated resume to raviranjankumar.Singh@iqvia.com
Job Description/Skills Required
Roles and Responsibilities
- Serve as a stand-alone global lead for aggregate reporting, signal management, or literature survellance 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.
- 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), 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), Business development (BD) and Proposals, and Information Technology (IT), as needed
- Participate in internal and external audits, as required. Lead audit preparation activities in advance to audit and ensure audit readiness of project
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