Drug Safety Associate - 6-Month Contract

Innomar Strategies; Canada; Hybrid; CAD 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Medical benefits

Dental benefits

Vision care

Parental leave

Career development

Zusammenfassung

Cencora, Inc. is seeking a Drug Safety Associate in Canada to review, document, and submit adverse event information and product quality reports in line with SOPs and regulatory requirements.

The role involves data entry, literature screening, and supporting quality and CAPA activities. The candidate will bring 1–3 years in Medical Information, Clinical Research, or Drug Safety, with Life Sciences education and strong analytical and communication skills.

Qualifikationen

• Minimum college-level education with Life Sciences concentration is strong asset.
• 1–3 years in Medical Information, Clinical Research or Drug Safety or related field.
• Knowledge of pharmacovigilance guidelines (Canada/US/EMEA/ICH).

Aufgaben

• Receive, scan and document clinical information per SOP and legislation.
• Review source documents and triage adverse event information and complaints.
• Enter data and submit adverse event and product quality reports.
• Quality check adverse event reports as directed.
• Assist with data verification checks and literature screening.
• Prepare reconciliation reports and data clarifications.
• Support CAPA/non-conformance processes as needed.

Kenntnisse

Analytical skills

Effective communication

Interpersonal skills

Organizational skills

Attention to detail

Deadline-driven

Problem-solving

MS Word

MS Excel

MS PowerPoint

Ausbildung

Life Sciences diploma/degree

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Jobbeschreibung

About the company

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.

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:

Knowledge of Pharmacovigilance industry including up to date knowledge of; pharmacovigilance guidelines of Health Canada, US FDA, EMEA and ICH.

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.