• Mumbai City

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 naveenkumarbvrpccom

Salary Not Disclosed by Recruiter

Industry Pharma / Biotech / Clinical Research

Functional Area Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category Drug Regulatory Affairs/Documentation

Role Documentation/Medical Writing

Employment Type Permanent Job, Full Time
,

EducationUG -MBBS - Medicine, BPharma - Pharmacy, BDS - Dentistry, BSc - Any Specialization, BHMS - Any Specialization, BAMS - Any Specialization
PG - MPharma - Pharmacy, MDS - Any Specialization, Any Specialization, Medical-MS/MD - Neuro Surgery, Any Specialization, Neuro Surgery, MS/MSc(Science) - Any Specialization

Profile Summary:

Employment Type : Full Time
Industry : Pharma / Biotech
Salary : Not Disclosed
Deadline : 19th Apr 2020

Key Skills:

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