PRIMARY DUTIES AND RESPONSIBILITIES:

• Receive scan and document all pertinent clinical information in compliance with SOP/protocol and applicable legislation
• Work directly with internal and external clients to request additional information or clarification as necessary;
• Review of source data documents (includes visit report/PIR review) and triaging adverse event information and product quality complaints as per client needs;
• Data entry and submission of adverse event information and product quality complaints into program specific databases;
• Sorting and filing of incoming documents;
• Perform quality check on adverse event reports as directed by the work instructions
• Assist with and/or perform source data verification checks
• Screening medical and scientific literature for safety information
• Preparation of Reconciliation (weekly monthly etc.) Reports
• Transcription translations and redaction activities
• Preparation and conducting solicited follow-up letters and data clarifications
• Assist and participate in the non-conformance/CAPA process
• The Drug Safety Associate will also be assigned other duties and tasks as required from time to time
• May be required to be on standby/on call as part of this role.

Experience and Education Requirements:

• Minimum college level education required. A diploma or degree with a concentration in Life Sciences is a strong asset;
• 1-3 years experience in Medical Information Clinical Research or Drug Safety or equivalent and related experience in pharmacy or pharmaceutical fields;
• Knowledge of Pharmacovigilance industry including up to date knowledge of; pharmacovigilance guidelines of Health Canada US FDA EMEA and ICH;
• Adaptability to change and to learn new skills as required;
• Experience in the medical and/or pharmaceutical field(s) medical terminology is an asset;
• Bilingual English/French is an asset.
• Able to work any 8-hour shift between 8:00 AM-8 PM if necessary

• MINIMUM SKILLS KNOWLEDGE AND ABILITY REQUIREMENTS:

• Strong analytical skills
• Ability to communicate effectively both orally and in writing
• Effective interpersonal skills
• Effective organizational skills; ability to multitask
• Superior proven attention to detail
• Ability to consistently meet deadlines
• Excellent problem-solving skills; ability to communicate and/or resolve issues effectively and efficiently
• Computer skills (including knowledge of Microsoft Word Excel PowerPoint and other Office Programs)
• Good internet required for remote work

PRIMARY DUTIES AND RESPONSIBILITIES:

• Receive scan and document all pertinent clinical information in compliance with SOP/protocol and applicable legislation
• Work directly with internal and external clients to request additional information or clarification as necessary;
• Review of source data documents (includes visit report/PIR review) and triaging adverse event information and product quality complaints as per client needs;
• Data entry and submission of adverse event information and product quality complaints into program specific databases;
• Sorting and filing of incoming documents;
• Perform quality check on adverse event reports as directed by the work instructions
• Assist with and/or perform source data verification checks
• Screening medical and scientific literature for safety information
• Preparation of Reconciliation (weekly monthly etc.) Reports
• Transcription translations and redaction activities
• Preparation and conducting solicited follow-up letters and data clarifications
• Assist and participate in the non-conformance/CAPA process
• The Drug Safety Associate will also be assigned other duties and tasks as required from time to time
• May be required to be on standby/on call as part of this role.

EXPERIENCE AND EDUCATION REQUIREMENTS:

• Minimum college level education required. A diploma or degree with a concentration in Life Sciences is a strong asset;
• 1-3 years experience in Medical Information Clinical Research or Drug Safety or equivalent and related experience in pharmacy or pharmaceutical fields;
• Knowledge of Pharmacovigilance industry including up to date knowledge of; pharmacovigilance guidelines of Health Canada US FDA EMEA and ICH;
• Adaptability to change and to learn new skills as required;
• Experience in the medical and/or pharmaceutical field(s) medical terminology is an asset;
• Bilingual English/French is an asset.
• Able to work any 8-hour shift between 8:00 AM-8 PM if necessary

MINIMUM SKILLS KNOWLEDGE AND ABILITY REQUIREMENTS:

• Strong analytical skills
• Ability to communicate effectively both orally and in writing
• Effective interpersonal skills
• Effective organizational skills; ability to multitask
• Superior proven attention to detail
• Ability to consistently meet deadlines
• Excellent problem-solving skills; ability to communicate and/or resolve issues effectively and efficiently
• Computer skills (including knowledge of Microsoft Word Excel PowerPoint and other Office Programs)

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.

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

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

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