Pharmacovigilance Associate

Pharmacovigilance (PV) Associate supports the operations of PV processes for the APAC region ensuring compliance with internal procedures, contractual agreements and national / international regulations / standards / guidelines for PV of Clinigen licensed and unlicensed products (medicines, devices and biologicals). The role will work alongside the PV team and include coverage of Australia, New Zealand, Singapore, Hong Kong, Malaysia and neighbouring South East Asian countries.

Major Tasks & Activities :

Accuracy of information

• Manage and maintain efficient PV system and tasks as per safety agreements and local legislations
• Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Link-related products ensuring accuracy according to timelines from clinical trials, non-interventional studies, literature, Spontaneous Reports, Managed Access Programs, etc
• Manage reporting / submission / distribution of safety reports / updates / information to Local Health Authorities in cooperation with internal stakeholders
• Establish and coordinate reconciliation activities with other departments and contractual partners in line with local PV SOPs and regulation
• Conduct periodic literature search to identify safety-related information for Link-related products
• Transcribe and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality
• Manage reporting / submission / distribution of safety reports / updates / information (e.g., SAE, SR, IN / SUSAR, PSUR, Biannual SUSAR Listing, DSUR, Annual product reports) to Local Health Authorities and / or clinical operations in cooperation with other local departments
• Perform reconciliation with other departments and business partners for potential AEs resulting from medical inquiries, quality related complaints and other sources
• Conduct periodic literature search to identify safety-related information
• Input, review and approval of market research proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information as part of business development activities or for new product support
• Manage and maintain efficient pharmacovigilance filing and archive system

Accuracy of information

Operational

Outcomes

Personal Development

Additional duties :

This list of duties is not intended to be exhaustive but gives a general indication of the tasks involved. It is the nature of the company that tasks and responsibilities are, in many circumstances, unpredictable and varied. All employees are, therefore, expected to work in a flexible way when the occasion arises and acknowledge that tasks not specifically covered in their job description are not excluded.

Requirements

Benefits