Pharmacovigilance Manager
Company: Belcan
- Location: Los Angeles, United States
- Seniority: Senior
- Employment type: Contract
- Posted: Yesterday
- Offer language: English
Job description
Job Title : Pharmacovigilance Specialist
Location : Los Angeles, CA 90001
Duration : 12+ Months
Pay Rate : $50/HR On W2 (No Benefits)
Summary:
Provides operational support for global pharmacovigilance activities of Client 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 Client 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
Belcan is an equal opportunity employerYour application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
