Experience in pharmacovigilance operations, including adverse event processing and follow-up
Proficiency in data review, compilation, and analysis using an integrated safety database
Knowledge of regulatory reporting timelines and preparation of periodic safety update reports
Experience with PV compliance activities such as case reconciliation, audits/inspections, CAPAs, and PV procedures
Requirements:
Manage adverse event case processing, follow-up, and regulatory notifications/requests
Review literature, draft/manage periodic safety update reports, evaluate safety profiles, and manage signal detection and archiving
Ensure pharmacovigilance compliance through case reconciliation with departments, affiliates, distributors or partners, audits/inspections, and CAPAs; update PV procedures
Provide training and support for global PV operations, SOPs, and advisory activities including product monographs and regulatory responses; assist in drafting PV contracts and agreements
Job description
Pharmacovigilance Specialist Remote
Pay 40-50hr
Summary: Provides operational support for global pharmacovigilance activities of marketed products. Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. Responsible for data review, compilation, and analysis, including management of the integrated safety database.
Primary responsibilities for the role:
Management of Adverse Events including activities such as processing adverse event case reports and conducts follow-up.
Notifies regulatory agencies and business partners accordingly; responds to requests from regulatory agencies.
Reviews scientific literature and bibliographic sources; draft and manage periodic safety update reports.
Evaluates safety profiles; draft and manage signal detection reports; ensures document filing and archiving.
Participation in the processes of involving the collection, processing, review and distribution of adverse event information regarding development and marketed pharmaceutical products.
Contributes to ensure compliance of pharmacovigilance activities including activities such as conduct 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 managing 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 monographs review, draft responses to pharmacovigilance requests from regulatory agencies; participates in the drafting and implementation of pharmacovigilance contracts and agreements.
