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
• Responsible for narrative writing for all adverse or other reportable events received alone or in combination with a product complaint or medical information question.
• Work directly with internal and external clients to request additional information or clarification as necessary;
• Review patient information in database and ensure accurate documentation as per client needs;
• Data entry of event information and pertinent details;
• Reconciliation of event reports;
• Submit ICSR cases to Regulatory Authorities and/or our clients as per the applicable client process/es
• Perform duties of Local Safety Officer upon client assignment (eg. HC Vigilance Database monitoring local literature searches and regulatory intelligence)
• Act as a subject matter expert and provide audit and inspection assistance
• Train other staff training and perform quality checks as needed
• Assist with performing source data quality checks and verification which includes documentation and correspondence with external teams
• Assist with compliance reports including CAPA/Event Report Management
• Assist Manager in client meetings and provide relevant inputs to ensure customer expectations and Pharmacovigilance obligations are met correctly
• Other tasks assigned by the Manager as needed.
• May be required to be on standby/ on call as part of this role.

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

• Bilingual English/French strongly preferred
• Bachelors degree in health-related discipline or diploma in a life sciences program
• 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
• Computer skills (including knowledge of Microsoft Word Excel PowerPoint and other Office Programs)
• Good internet required for remote work

What Cencora offers

We provide compensation benefits and resources that enable a highly inclusive culture and support our team members ability to live with purpose every addition to traditional offerings like medical dental and vision care we also provide a comprehensive suite of benefits that focus on the physical emotional financial and social aspects of wellness. This encompasses support for working families which may include backup dependent care adoption assistance infertility coverage family building support behavioral health solutions paid parental leave and paid caregiver leave. To encourage your personal growth we also offer a variety of training programs professional development resources and opportunities to participate in mentorship programs employee resource groups volunteer activities and much more.

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Equal Employment Opportunity

Cencora 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.

The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Accessibility Policy

AmerisourceBergen is committed to fair and accessible employment requested AmerisourceBergen will accommodate people with disabilities during the recruitment assessment and hiring processes and during employment.