Pharmacovigilance Associate

at  Clinigen

Are you looking for the next step in your career? We’re searching for a Senior Pharmacovigilance Associate to join our team to provide high quality operational processes locally and across the region. You’ll play an integral part of delivering our mission: to deliver the right medicine, to the right patient, at the right time.
Day to day, this role will see you deliver operational processes and ensure compliance with internal procedures, contractual agreements, national and international regulations/standards/guidelines for pharmacovigilance across a range of commercial and unlicensed products. You’ll work closely with our regional PV Lead, as well as all teams across our business to ensure the highest standard of service.

DAY TO DAY, THIS ROLE WILL SEE YOU:

• Manage collection, processing, documentation, reporting and follow-up of all adverse event reports Process orders in a timely manner
• Prepare reporting / submission / distribution of safety reports / updates / information to Health Authorities and/or clinical operations in cooperation with other local departments
• Transcribe and enter data of all data from source documents into safety systems Support internal and external audits corrective action plan, investigations, and Health Authority inspections
• Perform reconciliation with other departments and business partners for potential adverse events
• Support the preparation, negotiation, approval, and maintenance of local/regional pharmacovigilance agreements
• Act as Contact Person for your assigned territory.

TO BE SUCCESSFUL IN THIS ROLE YOU’LL NEED:

• Demonstrated experience as a Health Care Sciences Professional
• Tertiary qualifications in Medical, Medical Science, pharmacy or other related healthcare disciplines
• Demonstrated experience in a Pharmacovigilance role
• Knowledge of national and international regulations for pharmacovigilance
• Experience in identification of critical situations/emerging safety issues from drug safety point of view
• Good understanding of signal detection and risk management
• Excellent written and spoken English communication skills, with Mandarin and Cantonese language skills beneficial