Allergan Senior Product Surveillance Analyst in Pleasanton, California

Senior Product Surveillance Analyst

Pleasanton, California, United States at https://agn.referrals.selectminds.com/jobs/5605/other-jobs-matching/location-only

Jun 06, 2018Post Date

180415Requisition #

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.

Position Description

The primary responsibility of this position is the investigation, analysis, resolution, trending and corrective action of escalated adverse event (AE) complaints. Specific responsibilities include; maintaining the complaint files and supporting the resolution of the complaint, as applicable. Additionally, this position may provide input to the safety and report ability assessment of complaints.

Main Areas of Responsibilities

  • Review of calls to identify and categorize complaints

  • Be able to work independently and give guidance to junior staff on the adverse event complaint process.

  • Establishes and maintains complete complaint files for escalated customer complaints

  • Utilizing medical background, this position is responsible for investigating complaints to assist in resolution of both product/AE issues determined through failure analysis, focusing on root cause analysis

  • Reviews and analyzes customer complaint information for trending/risk analysis and corrective action and effectiveness of action

  • Interfaces with customer service and technical service and other groups on a daily basis to drive timely completion of complaints

  • Communicates directly with customers and/or the medical community to investigate and resolve complaints

  • Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, investigating and resolving complaints

  • Maintains compliance to internal complaints procedure, FDA, ISO and Canadian medical device regulations

Requirements

  • Certification/degree in nursing, bachelors’ degree in science or other technical discipline or a minimum of 5 years’ relevant work experience, preferably in nursing

  • Minimum of 5 years of experience in FDA regulated medical device manufacturing environment(s) preferred

  • Knowledge of QSR, 13485:2003, and 14971:2007

  • Problem solver

  • Self-directed

  • Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.

Education

  • Certification/degree in nursing, bachelors’ degree in science or other technical discipline or a minimum of 5 years’ relevant work experience, preferably in nursing

Equal Employment Opportunity Employer

Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.