Global Pharmacovigilance & Patient Safety Associate

Poolia Life Science are looking for a Global Pharmacovigilance& Patient Safety Associate for a 6-month consulting assignment at our customer, a biopharmaceutical company in Stockholm. Do you have a genuine interest in patient safety and strong administrative skills? Please don't hesitate and submit your application today!



KEY RESPONSIBILITIES

Support collection, processing, follow-up, reporting, documenting, archiving and reconciliation safety data for all types of individual case safety reports (ICSRs)

• Contribute to management of GPV Operations mailboxes.
• Contribute to receipt, tracking, monitoring and documentation of ICSRs
• Contribute to follow up of ICSRs including tracking of activities performed
• Contribute to tracking of acknowledgements for ICSRs sent to partners
• Contribute to reconciliation of safety data with Sobi partners and internally within Sobi
• Create reports as required from the Safety database for the purpose of safety surveillance and regulatory submission acitivties
• Support data entry and quality control of ICSRs within the case-handling process.
• Support exchange of ICSRs with internal and external sources, and to regulatory reporting.
• Contribute to the introduction and training of new staff.
• Provide support to administrative processes at the Drug Safety Department including archiving and tracking of receipt of ICSRs

QUALIFICATIONS

Desired:
• University level qualification in biosciences or healthcare
• At least 1 years’ experience post-graduation in the pharmaceutical industry

Skills/Knowledge/Languages Required:
• Computer literate
• Fluent in English

Personal Attributes:
• High Ethical Standards
• Delivery focus
• Good attention to detail
• Able to work effectively both independently and collaboratively across the department
• Team player.