Vigilance Associate - Toronto, Canada - Fresenius Kabi Canada

Fresenius Kabi Canada

Verified Company

Toronto, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

_Caring for Life. Make a difference. Be the difference._

If you are looking to work for a growing, global corporation that is focused on making meaningful improvements in the safety, affordability, and availability of the care medical professionals provide to their patients, then you should consider Fresenius Kabi.

We are an employer that works to build great leaders, teams and businesses.

We know our employees are key to everything we accomplish, so we give them the freedom and resources to reach their potential and the opportunity to work with managers who care about their professional development.

We value integrity, encourage collaboration, celebrate passion, reward creativity, and demand excellence — because our customers deserve nothing less and our customers are at the heart of every one of our goals.

As a part of Fresenius Kabi, you can enjoy an exciting career, a company culture based on a clear purpose and values, and the knowledge that your work makes a real difference.

If you would like to learn more about us, we would love to hear from you.

Fresenius Kabi Canada is seeking a temporary full-time
Vigilance Associate to join our growing Vigilance team This is a contract for 14 months, and is based in the Greater Toronto Area with a hybrid working arrangement.

The Impact You Will Make:

The Associate, Vigilance will assist the Vigilance team with safety data processing, evaluation, reporting, record keeping and quality control in accordance to Health Canada guidelines and Global Vigilance requirements.

They will manage safety data reported in accordance with corporate and regulatory requirements for pharmaceuticals and medical devices for the organization.

Pharmacovigilance

Maintains high compliance standards with respect to reporting timelines and quality of local adverse drug reactions (ADR) data
Keeps uptodate regarding Canadian and international regulatory developments in the Pharmacovigilance area
Collects and processes adverse drug reactions from all sources
Submits all reportable cases according to local legislation
Initiates and conducts followup activities related to local ADR reports
Assists with regular reconciliation of ADR cases reported directly to Health Canada
Assists with PV training
Assists with the PSURs compilation for local products
Assists with PSP registry
Assists with screening of medical information enquiries for ADRs

Medical Device Vigilance

Reviews incoming domestic and international complaints and field actions daily to determine reportability based on Health Canada Medical Devices Regulations (MDR) and requirements.
Assists in evaluating the reportability of the events based on regulatory knowledge and/or clinical experience.
Assists with the submission of MDR reports within the timeframes specified by Regulations.
Assists with Medical Device Vigilance training.
Maintains high compliance standards with respect to reporting timelines and quality of local ADR data, medical devices mandatory problem reporting.

What You'll Bring
- _ Knowledge & Experience._ You possess a degree in Pharmacy, Nursing, Medicine or equivalent Bachelor of Science degree in Health Sciences, Pharmacy or Biomedical Sciences. You also have a minimum of 3 years of experience in Pharmacovigilance/Medical Information and/or Medical Device Vigilance. You have knowledge of relevant Health Canada regulations and ICH guidelines pertaining to Pharmacovigilance and Medical Devices. You have extensive knowledge and experience with safety case processing.
- _ Communication & Presentation. _You have strong scientific writing skills. Written or spoken French is an asset
- _ Problem-solving. _Your critical thinking and decision-making skills are above average, and you demonstrate excellent analytical skills and high level of accuracy. You identify and assess issues/ problems and present solutions with a process-improvement mindset.
- _ Attitude & Passion_. You are self-motivated, possess initiative, and able to work productively with mínimal supervision. You have proven your ability to adhere to standards and procedures and maintain continuous confidentiality.
- _ Exceptional organizational and time management skills_. You maintain strong attention to detail with the ability to multitask and handle fluctuating workloads simultaneously. You have excellent project management and follow up skills and are deadline oriented with a strong ability to prioritize tasks.
- _ Technical experience_. You are proficient in Microsoft Office, PowerPoint and Excel.

What We'll Bring
- _ Exposure_. The hands-on experience and exposure to a global organization. The opportunity to combine and develop your skills in both Pharmacovigilance and Medical Device Vigilance.
- _ Positive Collaborative Environment._ A welcoming, fun and energetic team environment that encourages open communication and collaboration. Our culture encourages our employees to hone curr