Pharmacovigilance Specialist
3 weeks ago
We are seeking a skilled Pharmacovigilance Specialist to provide operational support for global pharmacovigilance activities of marketed products. This role involves ensuring high-quality pharmacovigilance deliverables and meeting global regulatory reporting timelines.
The ideal candidate will have experience in data review, compilation, and analysis, including the management of integrated safety databases.
Key Responsibilities:
- Management of Adverse Events, including processing adverse event case reports and conducting follow-up.
- Notification of regulatory agencies and business partners, as well as responding to requests from regulatory agencies.
- Review of scientific literature and bibliographic sources, with drafting and managing periodic safety update reports.
- Evaluation of safety profiles, with drafting and managing signal detection reports, ensuring document filing and archiving.
- Participation in the collection, processing, review, and distribution of adverse event information regarding development and marketed pharmaceutical products.
- Contribution to ensuring compliance of pharmacovigilance activities, including conduct case reconciliation with concerned departments, affiliates, distributors, or business partners.
- Participation in self-inspection visits, audits, inspections, and CAPAs management, creating or updating pharmacovigilance procedures and working practices.
- Provision of training to concerned persons based on the training plan and managing training documentation; archiving 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.
- Serving in an advisory capacity, including activities such as product monographs review, draft responses to pharmacovigilance requests from regulatory agencies, participating in the drafting and implementation of pharmacovigilance contracts and agreements.
Estimated Salary: $42-$52/hr, Los Angeles, CA, hybrid schedule.
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