18 Unichem Laboratories Jobs

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