Associé Bilingue de la Pharmacovigilance / Bilingual Drug Safety Associate

Innomar Strategies; Ontario; Hybrid; CAD 45,000 - 70,000; Full time

Job summary

An innovative company dedicated to creating healthier futures is looking for a Drug Safety Associate. In this role, you will be at the forefront of health, ensuring compliance with protocols while managing critical clinical information. Your analytical skills and attention to detail will be essential as you work with both internal and external clients, triaging data and preparing reports. This position offers a dynamic work environment where you can make a real difference in the lives of people and animals everywhere. Join a team that values inclusivity and supports your professional growth through comprehensive benefits and development opportunities.

Benefits

Medical Insurance

Dental Insurance

Vision Care

Wellness Benefits

Paid Parental Leave

Professional Development

Mentorship Programs

Qualifications

• Minimum college-level education; a diploma or degree in Life Sciences is a strong asset.
• 1-3 years experience in Medical Information, Clinical Research, or Drug Safety.

Responsibilities

• Receive, scan, and document clinical information in compliance with SOP/protocol.
• Work with clients to request additional information or clarification as necessary.
• Perform quality checks on adverse event reports as directed.

Skills

Analytical Skills

Effective Communication

Interpersonal Skills

Organizational Skills

Problem-Solving Skills

Attention to Detail

Education

Diploma or Degree in Life Sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

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. Apply today!

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 source data documents (including visit report / PIR review) and triage adverse event information and product quality complaints as per client needs.
• Enter data and submit adverse event information and product quality complaints into program-specific databases.
• Sort and file incoming documents.
• Perform quality checks on adverse event reports as directed by the work instructions.
• Assist with or perform source data verification checks.
• Screen medical and scientific literature for safety information.
• Prepare reconciliation reports (weekly, monthly, etc.).
• Handle transcription, translations, and redaction activities.
• Prepare and conduct solicited follow-up letters and data clarifications.
• Assist and participate in the non-conformance / CAPA process.
• The Drug Safety Associate may be assigned other duties and tasks as required.
• May be required to be on standby / on call as part of this role.

Experience and Educational Requirements :

• Minimum college-level education; a diploma or degree in Life Sciences is a strong asset.
• 1-3 years experience in Medical Information, Clinical Research, Drug Safety, or related fields.
• Knowledge of pharmacovigilance guidelines of Health Canada, US FDA, EMEA, and ICH.
• Adaptability to change and willingness to learn new skills.
• Experience in medical or pharmaceutical fields; medical terminology knowledge is an asset.
• Bilingual in English / French is an asset.
• Ability to work any 8-hour shift between 8:00 AM and 8:00 PM, if necessary.

Minimum Skills, Knowledge, and Abilities :

• Strong analytical skills.
• Effective oral and written communication skills.
• Interpersonal skills.
• Organizational skills with ability to multitask.
• Attention to detail.
• Ability to meet deadlines consistently.
• Problem-solving skills and effective issue resolution.
• Proficiency in Microsoft Word, Excel, PowerPoint, and other Office programs.
• Good internet connection required for remote work.

What Cencora Offers

We provide compensation, benefits, and resources that foster an inclusive culture and support our team members' purpose-driven lives. Our offerings include medical, dental, vision care, and a comprehensive suite of wellness benefits, including support for families, backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental and caregiver leave. We also offer training programs, professional development, mentorship, employee resource groups, volunteer activities, and more.