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Regulatory Safety Writer Lead

1 week ago

Delhi, Delhi, India myGwork Full time

The role of a Medical Writer I at myGwork involves managing and preparing various safety reports, including aggregate reports, Clinical Study Reports (CSRs), and Health Authority responses. As a key member of the team, you will be responsible for ensuring the accuracy, completeness, and high quality of these documents.

Key Accountabilities:

  • Scheduling and attending meetings, drafting meeting agendas and minutes, and tracking action items.
  • Managing scheduled and unscheduled aggregate reports, including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), and Corporate Addendum Reports.
  • Preparing narratives associated with client/sponsor products from clinical trials for CSRs or to support health authority requests in accordance with regulatory and client/sponsor requirements.

Clinical Study Report Narratives:

  • Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client.
  • Ensures medical cohesiveness and assessment in accordance with client's and Parexel's conventions/guidelines and Standard Operating Procedures.

Signal Detection and Management:

  • Performs signal detection review and analysis from various sources, e.g., regulatory authority database, client database, literatures, regulatory authority websites, etc.
  • Responsible for the end-to-end signal management process, including signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc., in collaboration with the safety science.

Maintaining Knowledge and Expertise:

  • Maintains a good working knowledge of adverse event safety profiles of assigned drugs, labeling documents, client's guidelines, procedures, and SOPs, and international drug safety regulations.
  • Awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.

Required Skills and Qualifications:

  • Analytical and problem-solving skills.
  • Excellent interpersonal skills.
  • Excellent verbal/written communication skills.
  • Excellent organizational and prioritization skills.
  • Client-focused approach to work.
  • Ability to evaluate data and draw conclusions independently.