Pharmacovigilance Specialist

PHARMACOVIGILANCE (PV) SPECIALIST

COMPANY INFO:

MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries.  We specialize in the nationwide recruitment of clinical trials personnel.

 

Our clients is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential and is seeking to add a Pharmacovigilance (PV) Specialist to their team in Irvine, California.

 

RESPONSIBILITIES:

Responsible for the receipt, collection, processing and reporting of adverse event reports. Receives adverse event reports, enters data in adverse event database, selects term verbatim, determination of seriousness and expectedness, and determine follow-up needs. Obtains follow-up information from health care providers and works with PV physician to finalize reports for global reporting. Interface with groups handling non-medical complaints, complaint sample testing, and labeling functions within the company as related to adverse events. Assists in appropriate data analysis and other PV activities including training, process re-engineering, and system testing as needed.

- Has complete ownership and management of assigned AE cases and workload. Receives adverse event reports via the telephone, fax and email, and enters initial and follow-up information adverse event database. Reviews adverse events for seriousness, expectedness, and follow-up needs with input from PV physician and local affiliates world-wide.

- Generates reports and performs database reviews for PV related activities within Company, eg. line listings, aggregate reporting, signal generation, and pharmacoepidemiology activities.

- Provides support to non-medical complaints, labeling, marking, clinical and medical information groups for safety-related issues. Other related responsibilities: maintaining metrics, case reconciliation and report generation.

- Participates in training activities for PV-related issues and processes. Responsible for quality and timely processing of safety reports for distribution to US FDA and notification to internal and external business partners.

 

QUALIFICATIONS:

- Appropriate experience and certification (nurse, pharmacist, epidemiologist, physician, assistant) with 3+ years of relevant experience.

 

EDUCATION:

- Scientific degree with 5+ years performing PV duties related to specific areas (dermatology, ophthalmology, and/or neurology). 

 

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.