Drug Safety Pharmacovigilance Specialist
Company: Spectrum Pharmaceuticals, Inc.
Posted on: May 3, 2021
The individual in this position conducts case processing
activities for Spectrum's clinical and commercial drug and
biologics products to support product safety and compliance with
global drug safety regulations and departmental procedures.
- Receives safety related information from all sources, including
clinical trial cases, spontaneous reports, and literature reports
(U.S. and global).
- Performs triage for incoming cases, considering assessments of
seriousness, listedness, and causality.
- Performs accurate data entry into the safety database.
- Conducts MedDRA coding.
- Prepares high quality case narratives, including identifying
relevant information from source documents.
- Produces accurate safety reports (i.e. CIOMS/MedWatch Forms)
for submission to regulatory authorities and partners.
- Tracks due dates for partner submissions.
- Conducts reconciliation activities with partners.
- Conducts peer review of cases in the safety database for
- Produces queries as needed for clarification of clinical
- Conducts active follow-up, including written and verbal
- Conducts reconciliation of the safety and clinical databases
for serious adverse events.
- Supports the management of case processing deadlines.
- Extracts data from the safety database, as needed.
- Compiles safety information for aggregate safety reports and
other safety related reports
- Conducts departmental specific projects as needed.
Required Skills, Education and Experience:
- A degree in a healthcare discipline is required (e.g.
pharmacist, nurse, physician).
- Minimum of one year of safety experience in the pharmaceutical
- Understands local and applicable foreign safety
- Strong clinical background, with ability to interpret medical
records (e.g. laboratory results, medical conditions).
- Experience with use of safety databases, preferably Argus
- Strong written communication skills, with ability to write
clearly and concisely.
- Attention to detail and the ability to prioritize.
- Time management skills with ability to prioritize to meet
- Ability to collaborate with team members.
- Must be available to work in the evenings and weekends, as
Position Location and/or Territory and Travel:
- Position is located in United States (Irvine, CA or Cambridge,
- Position may require occasional travel.
Spectrum Pharmaceuticals is an equal opportunity employer, we
evaluate qualified applicants without regard to race, color,
religion, sex, national origin, disability, veteran status, and
other protected characteristics.
Keywords: Spectrum Pharmaceuticals, Inc., Irvine , Drug Safety Pharmacovigilance Specialist, Other , Irvine, California
Didn't find what you're looking for? Search again!