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Medical Reviewer

 

MMSH Clinical Research Pvt. Ltd. is part of MMS Holdings Inc., a global clinical research organization (CRO) that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. Our strong industry experience and scientific approach to drug development makes us a valuable partner in creating compelling submissions that meet rigorous regulatory standards. MMS' clients span from top 10 pharma to virtual biotechs, and we support each one with the same standard of excellence. Our core service areas include medical and regulatory writing, biostatistics, clinical programming, data management, clinical development, clinical trial disclosure, regulatory affairs, regulatory submissions and pharmacovigilance.

Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patients' lives worldwide.

 Roles & Responsibilities:

• 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

• Prepare 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

• Travel to client sites as necessary

• Ensure compliance to applicable QMS and ISMS policies and procedures

• Compliance to customer templates and ICH guidelines, as applicable

• Implement and validate QC findings as appropriate, in compliance with NC handling procedure

 Job Requirements

• Medical degree required (MBBS Only)

• 1+ years experience in technical or medical writing preferred

• Excellent scientific writing skills

• Ability to understand clinical data

• Proficiency with MS Office applications

• Good communication skills

• Familiarity with ISO 9001:2008 requirements

• Familiarity with ISO 27001 requirements

• Strong knowledge of current regulatory practices and domestic and international regulations

• Must have a minimum of 1 year clinical experience and/or research experience

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