Job Description
Our Client, a Pharmaceutical Company, is looking for Pharmacovigilance Specialist for their Los Angeles, CA/Hybrid location
Responsibilities: - 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.
- 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.
- 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.
- 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.
Requirements - 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.
Why Should You Apply? - Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws. Iconma LLC
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