IQVIA Released Job Openings On 22/11/2022.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.
IQVIA Recruiting B.Pharma, M.Pharma, Pharm.D, BDS, MDS, BAMS & BHMS with 04-08 Years Experience for Safety Aggregate Reporting Specialist Position.
Important Details :
- Location :Bangalore/Bengaluru( Marathahalli )
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: NA
- Opening date for online Application: 22/11/2022
- Mode of application :Online
- How To Apply: Candidates who are interested can please revert with your updated resume to raviranjankumar.Singh@iqvia.com
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Job Description/Skills Required
- 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’ signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ 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 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 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), and Information Technology (IT), as needed.
- Participate in internal and external audits and inspections, as required.
- Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
- Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
- Serve as the interface between the global project lead and the working team
- conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
- Provide mentorship and training to less experienced resources.