Senior Pharmacovigilance OfficerSenior Pharmacovigilance Officer

REF 1639893

06.10.2024 | Dubai | full time

Description: This is an exciting opportunity for a Senior PV officer to work in a dynamic and cohesive Pharmacovigilance team. The role is pivotal in ensuring accurate and timely processing of all individual and aggregate safety information and their submission to the US Health Authority and performing signal surveillance and Risk management activities for a diverse product portfolio covering specialty care, general medicines, vaccines and devices.

Senior Pharmacovigilance Officer Responsibilities:

-Ensure oversight of accurate and timely processing of PV data as per Sanofi procedures. This includes but is not limited to Individual and aggregate reports, SUSAR management, local signal detection/surveillance, safety exchange agreements, local literature monitoring and local risk management activities.
-Ensure the effective support of clinical or post authorisation study activities, Patient support programmes, Digital programmes and or Market Research programmes in relation to PV activities.
-Ensure that all processes and MCO Pharmacovigilance systems (including training) are in compliance with regulations and global company policies.
-Effectively support the creation, monitoring, review of the Quality management system within the PV department.
-Effectively support the PV Manager with the management of all assigned PV responsibilities.
-Act as representative of PV department in various internal forums or meetings.