Pharmacovigilance Specialist
Pharmacovigilance Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
Title: Pharmacovigilance Specialist
Location: 2410 Los Angeles CA 90032
Duration 12 months (Possible extension for long term)
FAQ
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.
The interview will consist of a phone screen with the local manager and a second phone screen with management in Barcelona. The team is based in LA but it is a global team and will need someone who can be flexible in scheduling meetings across multiple time zones.
Summary:
- Provides operational support for global pharmacovigilance activities of clients marketed products.
- Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. R
- Responsible for data review compilation and analysis including management of the integrated safety database.
- Management of Adverse Events including activities such as processing adverse event case reports and conducts followup .
- 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 involving the collection processing review and distribution of adverse event information regarding development and marketed clients pharmaceutical products. .
- Contributes to ensure compliance of pharmacovigilance activities including activities such as conduct case reconciliation with concerned departments affiliates distributors or business partners . T
- Take part in selfinspection 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. be sure to see notes before submitting candidates.
Employment Type
Full Time
