Marketing Surveillance (PMS)

• Author and review Aggregate Safety Reports (ie DSURs, PBRERs, PSURs, PADERs and Canadian Aggregate Reports) and any other aggregate reports as per requirement of the project
  
• Review aggregate safety data from the database and generate line listings (LL) and summary tabulations (ST) and include the LL & ST in the appropriate template
  
• Analyze safety and regulatory data provided by the client and prepare complete Aggregate Reports according to the client requirements
  
• Perform literature screening for inclusion of significant safety articles in respective section of aggregate reports
• Compile benefit risk evaluation sections provided by medical reviewers, as applicable
  
• Ensure you comply with internal and external timelines
• Address comments from internal and external/client reviewer(s)
• Finalize reports as per client requirements
• Participate in internal and external audits and inspections by clients and health authorities
  

• Screening, data mining and frequency tabulation for potential signals including signal estimation using appropriate signal detection tool as per the client requirement
  
• Generation of line listings and summary tabulations from Argus/client safety database
  
• Drafting Signal detection, validation, assessment and benefit-risk analysis and prioritization of signals by reviewing available data
  
• Ensuring compliance to appropriate signal SOPs, conventions and guidelines for all activities performed
  
• Tracking of identified signals from regulatory and internal signal detection process and monitoring the status of signals: potential signals, open signals, refuted signals and validated signals
  
• Developing Risk Management Plans and associated activities as per Navitas Life Sciences/client specific SOPs

• Ability to author and review Aggregate Safety Reports
• PBRER Aggregate Report experience
• Ably assist and support Individual Case Safety Report team as per the workload in respective teams
• Ably Assist and support Literature review team as per the workload in respective teams
• Assist in the scheduling of reports assigned to the team
• Good understanding of medical and Pharmacovigilance terminologies
• Good knowledge of GCP, GVP, ICH, USFDA guidelines and any other pharmacovigilance related guidelines and regulations
• Basic competence with medical and therapeutic terminology
  
• Strong understanding of patient safety regulatory obligations
  
• Familiar with regulatory and pharmacovigilance guideline
• Good command of written and spoken English; additional languages are favorable
• Good knowledge of usual office software (MS Office: Word, Excel, and PowerPoint)
• Soft skills (motivation, strong communication competence, structured in work, organizing skills, reliability commitment and capacity for teamwork)

Graduate or post graduate degree in life sciences, pharmacy, medicine, dentistry, allied health sciences and any other additional related courses