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Associate Pharmacovigilance Vikhroli, Mumbai

3.00 to 6.00 Years   Mumbai City   22 Oct, 2019
BVR People Consulting
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Designation: Associate Business Unit: Pharmacovigilance (Literature Case Processing) Exp: 3-6 Years Location: Vikhroli, Mumbai Shift Timings: 12 PM to 9 PM Responsibilities:

  • Conducts review of published literature Embase hits to identify ICSRs and other events of special interest Develops and maintains SOPs, as applicable.
  • Perform precision-based data structured field, Quality reviews of ICSRs to ensure compliance with data entry and processing conventions including, but not limited to, narrative compilation, MedDRA coding assessments and causality assessments.
  • Perform review of ICSRs, to ensure ICSRs processed in compliance with applicable departmental SOPs and conventions, including but not limited to the review of follow-up attempts.
  • Challenge ICSR level data quality issues and non-compliance to conventions/SOPs with the Service Provider as applicable.
  • Perform expectedness and listedness assessment checks and cross check on ICSR reportability based on Health Regulatory Authority (HRA) based submission rules.
  • Perform submission of ICSRs to regulatory authorities, company affiliates and Business partners in accordance with departmental SOPs and regulatory legislation.
  • Respond to queries related to ICSRs from stakeholders (including internal and external to company) in a timely manner.
  • Maintain departmental document management, including scanning and filing of source documents in accordance with Departmental SOPs.
  • Contribute to maintenance and compliance oversight of PV processes, external service providers and business partners.
  • Maintains user-level knowledge of Oracle ARGUS and MedDRA terminology.
Interested candidates kindly send your resume to naveenkumar@bvrpc.comSalary: Not Disclosed by RecruiterIndustry: Pharma / Biotech / Clinical ResearchFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, BiotechnologyRole Category: Drug Regulatory Affairs/DocumentationRole: Documentation/Medical WritingEmployment Type: Permanent Job, Full Time , Education:UG -MBBS - Medicine, B.Pharma - Pharmacy, BDS - Dentistry, B.Sc - Any Specialization, BHMS - Any Specialization, BAMS - Any SpecializationPG - M.Pharma - Pharmacy, MDS - Any Specialization, Any Specialization, Medical-MS/MD - Neuro Surgery, Any Specialization, Neuro Surgery, MS/M.Sc(Science) - Any Specialization

Keyskills :
dataentry dataquality qualityreviews serviceproviders documentmanagement complianceoversight narrativecompilation meddracoding pv bsc mds argus pharma filing meddra checks resume medical surgery cle

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