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Spec, Pharmacovigilance

Allergan, Inc.

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Location: Bridgewater, NJ Posted Date: 4/15/2013 Position Type: Full time Job Code: 130437 Required Education: High school or equivalent

Description

Under minimal supervision, the Pharmacovigilance Specialist is responsible for preparation, analyses, and follow-up of adverse event (AE) and serious adverse event (SAE) reports from post marketing or clinical sources. Assures data accuracy, clinically valid case assessment and regulatory reporting status assessment. May serve as a primary point of contact for specific projects in addition to providing Safety support on cross-functional project teams.  Responsible for the reconciliation of the safety database.  Contributes to the mentoring and training of new colleagues as needed.

Key duties and responsibilities:
ICSR Processing

ICSR processing which may include SAE narrative creation for clinical study reports
ICSR processing receipt, collection, processing and reporting of safety information cases (aka ICSRs).  
Receives ICSR information, enters data in adverse event database, selects terms verbatim, makes initial determination of seriousness, expectedness, listedness, and USA FDA reportability.
Determines case follow-up activities.  
Obtains follow-up from consumers and health care providers and works with Medical Safety Physician to finalize serious reports for global notification.
SAE Reconciliation

Performs and oversees the activities associated with the safety database reconciliation.
Process, Project Support

Participates in special projects and process development activities.
SOP development and Training

Assists in the developing and updating of SOP (and related documents) and staff training
Contributes to the mentoring and training of new colleagues

The employee must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements.  Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Requirements

Education and Experience:
Bachelor’s of Science degree required
Minimum of 6 years drug safety experience
RN, Nurse Practitioner, Physician Assistant or related healthcare experience preferred
Pharmaceutical industry experience preferred; Drug Safety case processing experience highly desirable
OR
A Master’s degree
Minimum of 4 year drug safety experience
Pharmaceutical industry experience preferred; Drug Safety case processing experience highly desirable
OR
A PhD
Minimum of 2 year drug safety experience
Pharmaceutical industry experience preferred; Drug Safety case processing experience highly desirable
Essential Skills and Abilities:
Good knowledge of medical terminology highly desirable
Working knowledge of relevant regulations and guidance documents governing both safety reporting and processing for clinical trial and post-marketing environment
Computer proficiency and computer data entry experience required
Strong organizational skills, detail oriented, ability to adapt in a fast paced constantly changing environment
Clear, effective written and verbal communication skills
Ability to work under pressure in order to meet tight deadlines
Good interpersonal skills (i.e. team player)
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