Pharmacovigilance Specialist
2410 Grifols Way , Bldg. R-431 Los Angeles, CA 90032 US
Job Description
- 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.
Pay Rate Range: $30-50/hr depending on experience
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