Required Skills

Aggregate safety reports PADER PBRER PSUR DSUR

Work Authorization

  • Citizen

Preferred Employment

  • Full Time

Employment Type

  • Direct Hire

education qualification

  • UG :- - Not Required

  • PG :- - Not Required

Other Information

  • No of position :- ( 1 )

  • Post :- 18th Nov 2022


Roles and Responsibilities

Aggregate SafEty Reports:

  • Support/lead end-to-end preparation of aggregate safety reports. Support coordination with other line functions including Regulatory Affairs team to ensure information received, analyzed and incorporated into ARs as per the regulatory requirements.
  • Retrieve and analyze the safety data from global safety database and ensure adequate presentation in the ARs.
  • Ensure a comprehensive and consistent aggregate analysis performed to establish the risk benefit profile of the product that meets all Health Authority (HA) requirements
  • Support in creating a strategy for data analysis and presentation in global periodic safety reports. Support in addressing the Health Authority (HA) comments adequately in PSURs.
  • Support in the development of safety document templates and Standard Operating Procedures pertaining to safety aggregate reports
  • Contribute to global projects focusing on process & quality improvement initiatives. Contribute as subject matter expert during Health Authorities inspections/audits and contribute in development, implementation of appropriate Corrective and Preventative Actions (CAPA).


  • Preparation of Risk Management Systems including but not limited to Risk Management Plans, Dear Healthcare Professional Letters and Risk Communication Plans
  • Manage safety related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly
  • Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to Group guidelines/SOPs
  • Coordinate production and distribution of draft and final documents to regulatory teams. Ensure that all work is complete and of high quality prior to team distribution
  • Attend internal and technical team meetings as required
  • Assist management as needed with preparation of resourcing estimates for potential new medical writing projects
  • Proactively engage with other departmental resources where necessary to ensure that information/documentation requests are delivered in a professional and timeous manner

Desired Candidate Profile

  • Results and performance driven deliver results that meet or exceed expectations
  • Sense of urgency responding to issues and opportunities in a timely manner
  • Intellectual curiosity willing to suggest and try new ideas
  • Positive and pro-active approach to business tasks
  • Excellent interpersonal and communication skills
  • A solutions provider with strong multi-tasking abilities
  • Manage evolving deadlines effectively with regular feedback and updates
  • Enthusiasm and Drive to take ownership and drive process initiatives


Company Information