Pharmacovigilance Associate

Mississauga - Ontario - Canada - Life Sciences & Health Care - Pharmaceutical - Research & Development - Academic Bachelor

We’re hiring a Pharmacovigilance Associate for our client, a Bio-pharmaceutical Company based in Mississauga.

This individual will support the patient Safety Department and the Medical Operations Manager with various Pharmacovigilance (PV) related processes and procedures and will also act as the deputy to the Medical Operations Manager.

Feel free to contact

Sinead McLaughlin, Account manager

Apply now

About this role

Responsibilities

  • Perform ongoing adverse event (AE) case reviews and report on trends on quality and reporting timelines from the Patient Support Program as per corporate requirements to ensure compliance against Statements of Work Key Performance Indicators (SOW KPIs) and Master Service Agreement

    (MSA).

  • Review of CAPAs to ensure quality and timeliness from 3rd party vendors to ensure compliance against SOW KPIs and MSA.
  • Perform safety trend analysis and metrics reporting from third party vendors
  • Monitor and manage requests or escalate issues from pharmacovigilance mailboxes to the Medical Operations Manager as appropriate
  • Conduct periodic Health Canada Line Listing Reconciliation as per internal process.
  • Support the Ipsen Call Centre in the handling of French product complaints if applicable
  • Clinical trials activities:

    - Support the building of infrastructure at Ipsen Canada for safety reporting of company sponsored studies (CSS) and local investigator-initiated studies (ISS) as per Ipsen and Health Canada requirements.

    - To inform Global Pharmacovigilance on all new local clinical trials and ensure that the required SUSARs are sent to investigators in Canada in accordance with local regulations.

  • Support integration of new or updated Global PV/Quality processes into local PV processes/SOPs/Working instructions.
  • Collaborate in developing and maintaining the local Pharmacovigilance SOPs and procedures.
  • Collaborate with the Medical Operations Manager in the management of internal and vendor CAPAs as required.
  • Work collaboratively with and/or provide support (ad hoc tasks, activities, and specific projects) as needed to the Medical Operations Manager/Local Safety Officer and the global PV team.
  • Act as deputy in absence of the department Medical Operations Manager
  • Maintain current knowledge of all relevant local Pharmacovigilance regulations and awareness of changes to regulatory Safety guidance documents and requirement.
  • Maintain regulatory compliance by ensuring that tasks are performed within specified timelines.

About you

Requirements

  • B.Sc. Pharmacy preferred but other Bachelor’s degree in life sciences with experience will beconsidered
  • 2 years’ experience in a similar position
  • 1-3 years prior pharmaceutical industry experience preferred (e.g., safety surveillance, safety report writing, risk management, activities in the clinical trial and post-marketing setting)
  • Experience with safety databases (ARISg or ARGUS) and systems
  • Experience with Medical Information database (IRMS) is an asset
  • Excellent communication skills.
  • A high level of motivation, a self-assured manner and able to manage multiple tasks.
  • Ability to work in a multidisciplinary team.
  • Excellent knowledge of Health Canada regulations and guidelines relating to Pharmacovigilance processes (e.g. post-marketing surveillance activities / clinical trial activities/ training).
  • Attention to detail and follow-through on commitments.
  • Excellent clinical interpretation skills based on limited information along with strong understanding of medical terminology.
  • Able to effectively coordinate safety related activities.
  • Professional and solutions oriented.
  • PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB226426
  • Location: Mississauga
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of Expertise: Research & Development
  • Closing date: Saturday, September 28, 2019
Apply now

Feel free to contact

SM

Sinead McLaughlin

Account manager Brunel Energy Canada Calgary

+1 403 539 5009

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