Pharmacovigilance Associate / Drug Safety Associate

Role & responsibilities

• Execute activities in the scope of ICSR management unit within agreed extent and timeframe.
• Determine and perform appropriate case follow-up, including generation of reply, dissemination of information & clarifications to the reporter, QA, etc. as required
• Perform ICSR follow-up activities with reporters, CRO, QC, etc.
• Manage submission of ICSR in the appropriate format (E2B XML) to regulatory authorities.
• Perform day-to-day operational activities of the Safety system & ensure compliance to SOPs and applicable regulations.
• Provide support for the handling processes pertaining to adverse events and product complaints.
• Interact with the concerned stakeholders for the purpose of safety data collection and data reconciliation.
• Contribute to the development and fulfilment of CAPAs.
• Conduct and support PV training activities.
• Providing client notifications as required for case management.
• Review of training materials and training delivery.
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• To act as a significant point for Case Management and regulatory reporting of ICSRs
• Handling direct reports on a day-to-day basis and calling out topics as needed to Senior Leadership.
• Support medical coding conventions, and systematic process improvements for ICSR review
• Provide expertise and guidance on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, SOP creation, and metrics with regards to ICSR processing
• Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor

Preferred candidate profile

• Strong verbal, written and interpersonal communication skills.
• High level of accuracy and attention to detail.
• Ability to identify and resolve problems in a timely manner.
• Able to work independently and collaboratively in a multi-disciplinary team.
• Excellent organization and prioritization skills; able to multitask

Interested applicants with relevant experience can apply directly with updated CV to hr@qpsbioserve.com