Remote Pharmacovigilance Specialist

Planet Pharma Group; Los Angeles (CA); Remote; USD 55,000 - 66,000; Full time

Job summary

Grifols seeks an operational pharmacovigilance support professional to ensure high-quality safety deliverables and regulatory timelines. You will manage adverse events, perform literature reviews, and support data compilation and analysis within the integrated safety database.

Responsibilities include adverse event processing, regulatory notifications, signal detection, audits, SOP updates, and training. This role involves collaboration across departments and external partners.

Responsibilities

• Management of Adverse Events including processing adverse event case reports and 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 processes involving collection, processing, review and distribution of adverse event information regarding development and marketed Grifols 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.

Job description

Summary

Provides operational support for global pharmacovigilance activities of Grifols 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 Grifols 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.

Pay Rate Range

40-48/hr depending on experience