Pharmacovigilance Specialist

Pharmacovigilance Specialist
02 Months (Possible extension upto a year)
Los Angeles, CA- Hybrid or Remote

Note: This is listed as starting in 2 months, but the plan is to extend this contract for up to a year. This position is for Adverse event monitoring. This person will deal with marketed products and side effects, follow up with reporters (patients, Doctors, etc.), and triage case reports. Looking for someone with a background in Pharmacovigilance who can follow international regulatory guidelines. Preference is for the ARGUS database. PSUR exp would be nice.

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.


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