We are looking for a Pharmacovigilance Associate I to join the clinical development division of Bionical Emas. This individual will work closely with the rest of the PV team What will your job look like? Perform the tasks of the Case Management Team Participate in client meetings and liaise with clients regarding ongoing projects Assist with establishing Bionical Emas and/or clients' pharmacovigilance systems including preparation and/or review of SOPs/WI Ensure accuracy and attention to detail in all tasks Ensure tasks are completed within set deadlines Report issues to PVG Project Leader
Head of Case Processing and/or applicable Project Manager Liaise with Pharmacovigilance Department re personal workloads
programme status & resource requirements When required
manage and support
pharmacovigilance case management activities including SAE case entry
regulatory assessment of SAEs and submission to relevant Authorities Ensure compliance with regulatory requirements including contribution to client and/or Bionical Emas quality systems Participation in client/potential client audits and regulatory authority inspections as required