Officer - PV- Medical writer

3 weeks ago

Mumbai, India Unichem Laboratories Full time

RESPONSIBILITIES

  • Responsible for management of scheduled and unscheduled aggregate reports including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), United States Periodic Adverse Drug Experience Reports (PADERs), Risk Management Plan (RMP), Health Hazard Evaluation (HHE).
  • Independent authoring, editing and reviewing of various regulatory/clinical documents.
  • Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions
  • Providing input and developing literature search strategies for the epidemiology section of safety reports
  • Ensuring that all work is complete and of high quality prior to distribution. Confirm data consistency and integrity across the document. Performs quality checks on the drafted documents as required.
  • Assists in compilation and formatting of the documents
  • Distributing of final reports and submission to health authorities, according to the agreed timelines, distribution lists and email templates (as required)
  • Evaluating and incorporating reviewer comments in draft reports and liaising with relevant contributors for resolution of comments
  • Mentoring new recruits in the team, if required
  • Archiving the source documents and relevant emails as required
  • Responding to clients/customers in a timely manner

Desired Skills

  • Expert knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, GVP Modules; respective EU Clinical Trial Directive etc.)
  • Good knowledge of regulatory documentation, drug development process and global regulations and guidelines.
  • Previous experience of pharmacovigilance medical writing, including PBRERs/PSURs, and RMPs
  • Ability to manage multiple and varied tasks and prioritize workload.
  • Attention to detail and decision-making skills.
  • Ability to effectively train and mentor Associate/Junior Medical Writers
  • Knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
  • Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting

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