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Medical Reviewer Job For MBBS / M.D Fresher – Bangalore MMSH Clinical Research Pvt Ltd

March 26th, 2013 Posted by Shane


Job Position: Medical Reviewer

Name of the Company: Mmsh Clinical Research Pvt Ltd

Job Location: Bengaluru/Bangalore

Experience: 0 to 2 yrs

Job Duties:

  • Provide significant expertise as primary medical reviewer of individual adverse event reports
  • Guide adverse event coding, retrieval and analysis activities in drug safety and clinical trials
  • Aggregate case analysis, safety summaries and safety signal generation
  • Lead safety activities on assigned product(s) that may include interactions with other functional groups in the company
  • Oversee the preparation of reports for submission to domestic and international regulatory agencies
  • Responsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations
  • Responsible for strategies in monitoring and analysis of cumulative safety information
  • Responsible for drug safety crisis management and Risk Management plans
  • Guide reviews of safety sections of NDA submissions
  • Guide regulatory reporting including individual case safety reports (ICSRs), NDA annual report summary statements, and periodic safety update reports (PSURs)
  • Guide and coordinate preparation of ad-hoc benefit-risk assessment documents
  • Plan cumulative safety information analysis such as signal detection from company or public databases with data mining.
  • Guide safety updates of company core data sheet and local product labels
  • Guide regulatory strategy and preparation of data related safety to regulatory authorities and advisory committees
  • Responsible for clinical writing
  • Interact with client matters related to changes and information required
  • Review blinded data tables for CSR writing
  • Address customer comments at each draft stage
  • Review documentation prior to release
  • Compliance to customer templates and ICH guidelines, as applicable
  • Implement and validate QC findings as appropriate, in compliance with NC handling procedure.

Skills Required:

  1. Bachelor of Medicine and Bachelor of Surgery – MBBS
  2. 0 – 2+ years experience in technical or medical writing
  3. Excellent scientific writing skills
  4. Ability to understand clinical data
  5. Proficiency with MS Office applications
  6. Good communication skills
  7. Familiarity with ISO 9001:2008 requirements
  8. Strong knowledge of current regulatory practices and domestic and international regulations
  9. Preferable to have a minimum of 1 year clinical experience and/or research experience.

Qualification: MBBS/M.S/M.D

Details of the Company:
MMSH Clinical Research Pvt Ltd, a growing pharmaceutical service organization (CRO), that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. We are a pharmaceutical service provider supporting pharmaceutical and biotech industries with medical writing, biostatistics, clinical programming, data management, clinical development, regulatory affairs, regulatory submissions and pharmacovigilance.

Contact Number: 91-80-40948717

Apply: Email your cv to nandini@mmsholdings.com,swamy@mmsholdings.com

Contact Person: Nandini Vijaisimha/ Swamy Rudramurt


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