Drug Safety Associate

Innomar Strategies Inc.; Quebec; Hybrid; CAD 55,000 - 75,000; Full time

Job summary

Innomar Strategies, a Cencora company, is seeking a Drug Safety Associate to support patient and provider safety data in Canada. You will receive, document and review clinical information, coordinate with clients, and enter adverse events into databases per SOPs.

Minimum college-level education is required; Life Sciences concentration is a strong asset. 1–3 years in Medical Information/Clinical Research or Drug Safety, with strong analytical, communication and organizational skills.

Qualifications

• College-level education is required.
• Life sciences concentration is a strong asset.
• 1–3 years in Medical Information, Clinical Research or Drug Safety or related field.

Responsibilities

• Receive, scan and document clinical information per SOP and legislation.
• Coordinate with internal and external clients to request information as needed.
• Review source data documents and triage adverse event information and product quality complaints.
• Data entry and submission of adverse event information into databases.
• Perform quality checks on adverse event reports as directed by work instructions.
• Assist with source data verification checks.
• Screening medical and scientific literature for safety information.
• Prepare reconciliation reports.

Skills

Strong analytical skills

Effective written and oral comunic

Interpersonal skills

Organizational skills

Attention to detail

Deadline-driven

Education

College-level education

Life Sciences concentration asset

Tools

Microsoft Word

Excel

PowerPoint

Office programs

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Job Details

This role is in support of Cencora’s patient and provider support and pharma commercialization services in Canada marketed through our Innomar Strategies business.

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

Education

• Minimum college level education required.
• A diploma or degree with a concentration in Life Sciences is a strong asset.

Work Experience

• 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.

Skills & Knowledge

• 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.

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 day. In 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

Full time 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 company’s 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 [e-mail]. 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 practices. When requested, Cencora will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.

Affiliated Companies

Innomar Strategies Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.