Are you looking to make a difference in a patient’s life?  At AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference.  As an organization, we are united in our responsibility to create healthier futures. Join us and Apply today!

What you will be doing

As of October 18, 2021, AmerisourceBergen requires all Canadian team members to be fully vaccinated and show proof of completed vaccine status at time of hire. If you cannot receive the COVID-19 vaccine due to a qualifying medical condition or sincerely held religious belief you will be required to follow AmerisourceBergen’s policy and process to apply for an exemption/accommodation

PRIMARY DUTIES AND RESPONSIBILITIES:

• Recognize and report Adverse Events using the appropriate forms

• Triaging and assessing cases for seriousness based on ICH definition for SAE/SADR

• Assess expectedness based on the global and local Product Monograph (as applicable)

• Responsible for expediting submission of domestic and foreign cases for products with NOC in Canada (HC) and in the USA (FDA) as per applicable guidelines

• Responsible for narrative writing for all adverse or other reportable events received alone or in combination with a product complaint or medical information question.

• Perform case evaluation, including causality, severity and seriousness assessments

• Information Management and Pharmacovigilance: Receive, scan and document all pertinent clinical information in compliance with SOP/protocol and applicable legislation;

• Address medical information inquiries

• Work directly with internal and external clients to request additional information or clarification as necessary;

• Assist in audit preparation

• Review patient information in database and ensure accurate documentation as per client needs;

• Data entry of event information and pertinent details;

• Literature searches

• Reconciliation of event reports;

• Cases Quality Control

• Prepare aggregate reports, including Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs)

• Submit ICSR cases to Regulatory Authorities and/or our clients

• Sorting of incoming faxes and documents; and

• Filing of source documentation

• Other tasks assigned by the Manager, as needed.

• May be required to be on standby/ on call as part of this role. 

What your background should look like 

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

• Bilingual, English/French strongly preferred

• Bachelor’s degree or higher in related discipline in a life sciences program/major

• 3-5 years’ experience in Drug Safety, Clinical Research and/or equivalent and related experience in the pharmaceutical industry;

• Familiarity with Adobe Pro an asset

• Can do attitude, with proven ability to meet strict deadlines

• Knowledge of medical terminology is a strong asset

• Able to work any 8-hour shift between 8:00 AM-8 PM, if necessary

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

• Strong knowledge of pharmacovigilance industry including up to date knowledge of; GUI 0102, GVP, ICH GCP MHRA, Canadian Food and Drugs Act, and US FDA guidelines an asset

• Advanced knowledge of pharmaceutical distribution industry

• Strong business and financial acumen

• Strong analytical and mathematical skills

• Ability to communicate effectively both orally and in writing

• Effective interpersonal and leadership skills

• Effective organizational skills, attention to details

• Ability to consistently meet deadlines

• Excellent problem-solving skills; ability to resolve issues effectively and efficiently

• Excellent presentation skills

• Knowledge of Microsoft Word, Excel, PowerPoint and other Office Programs

What AmerisourceBergen offers

We offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.

Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.

Schedule

Full time

Equal Employment Opportunity

AmerisourceBergen is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

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