Management of Adverse Events including activities such as processing adverse event case reports and conducting follow-up
Notifies regulatory agencies and business partners accordingly; responds to requests from regulatory agencies
Review scientific literature and bibliographic sources; draft and manage periodic safety update reports.
Evaluate safety profiles; draft and manage signal detection reports; ensure document filing and archiving.
Participation in the processes involving the collection, processing, review, and distribution of adverse event information regarding the development and marketed of Client pharmaceutical products.
Contributes to ensuring compliance of pharmacovigilance activities including activities such as conducting case reconciliation with concerned departments, affiliates, distributors or business partners
Take part in self-inspection visits, audits, inspections, and in CAPAs management, create or update pharmacovigilance procedures and working practices
Provide training to concerned persons based on the training plan and manage training documentation; archive documents according to prevailing standards
Support in the procedures of global pharmacovigilance operations such as Standard Operation Procedures (SOPs), internal business practices or working instructions.
Serves in an advisory capacity including activities such as product monograph review, and Draft responses to pharmacovigilance requests from regulatory agencies; participates in the drafting and implementation of pharmacovigilance contracts and agreements.
Requirements:
Looking for someone with a background in Pharmacovigilance who can follow international regulatory guidelines.