Senior Medical Writer

Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) report, Risk Management Plan (RMP), Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), 
Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs) as well as preparing document of comparison between local and global labeling document (if applicable) and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and signal detection and management (where applicable). 

• Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc. 
• Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO 
  Conduct/support signal detection and evaluation activities according to SOPs and guidelines 
• Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations 
• Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting
• Maintaining a good working knowledge of the assigned Clinical studies for narratives 
• Ensuring that all work is complete and of high-quality 
  Attending/conducting internal, drug safety and project specific training 
  sessions 
• Preparation for, participation in, and follow up on audits and inspections 
  Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits 
• Delegating work as appropriate to Associate Medical Writer and Medical Writer I 
• Striving to enhance client’s satisfaction based on feedback provided by the client 
• Imparting project specific trainings to the new starts as required.  
• Serving as the primary client contact, liaising and collaborating with the 
  relevant function at the client’s end to facilitate the delivery of high-quality 
  work 
• Evaluating and incorporating reviewer comments in draft reports and liaising with relevant contributors for resolution of comments.