Career Connections Canada Inc.
'Connecting great people with great companies'
Our client in Brampton is seeking an Associate, Drug Safety & Labelling to join their team.
What They Offer:
- A safe and clean; GMP regulated work environment
- Opportunities for career growth and development
- A competitive wage/salary
- Incentive bonus programs that are designed to reward employees for their individual contributions
- Benefit programs designed to support our employees and their families, including a comprehensive health & dental benefits package, group RRSP matching program, direct access to healthcare and well-being programs, and paid time off
- Employee training and organizational development programs including tuition reimbursement, internal mobility programs, and employee recognition programs
Assist all pharmacovigilance activities at Canada including Adverse Event (AE) management, Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and Signal detection.
Support business objectives by providing timely, balanced and comprehensive Medical Information on marketed products in order to promote safe, rational and effective use of and products. Provide support and oversight in other related Drug Safety activities including Pharmacovigilance Agreements and Product Quality.
The Labelling Associate is responsible for the initiation, review and approval of artwork in compliance with Health Canada requirements. In addition the associate will be responsible for preparing and filing the Product Monograph Safety Updates in a timely fashion.
Principal Duties and Responsibilities :
- Perform intake, follow-up and data review of adverse event (AE) cases
- Assessment, documentation, medical evaluation and processing of incoming AE cases. Review cases for expectedness and seriousness using either the local Product Monographs or investigator brochures as needed.
- Review literature screening results to identify AE reports from literature sources.
- Submission of expedited reports to Health Canada.
- Exchange relevant adverse event, drug safety and pharmacovigilance material with affiliates worldwide.
- Performing reconciliation with business partners and vendor for AE report exchanges
- Interact with French Medical Information and AE intake vendor to ensure complete and quality output and provide guidance on follow-up as needed.
- Handling product complaints related to adverse events.
- Provide medical information to customers related to English medical inquires on and products.
- Assist in Health Canada pharmacovigilance inspection in coordination with QA/QC department to ensure successful results
- Assist in quality review for company products on Periodic Safety Update Reports (PSURs), Risk Management Plans and Signal Evaluation Reports to ensure accuracy and completeness.
- Assist in reviewing pharmacovigilance agreements with license partners and distributors and ensure timely data exchange with affiliates and partners
- Assist in developing and conducting AE reporting training for sales force as needed
- Other PV responsibilities as assigned but not limited to the above
- Regularly monitor and assess Canadian Reference Product labeling updates and submit PM safety update within the stated timeline.
- Work closely with Artwork Management, Packaging and Marketing departments to facilitate labeling implementation.
- Review internal labelling documentation for adherence to regulatory guidelines.
- Prepare submissions in eCTD format which involves full understanding of the use of Adobe Acrobat to create bookmarks and links.
- Review and file post approval submissions to Health Canada for revised labelling.
- Prepare written responses to deficiency letters from Health Canada in the stated time frame.
- Assist in the review and development of procedures, guidelines and maintenance system for labelling development, approval and control.
- Ensure documentation is maintained, both hardcopy and electronically.
- Other duties as required by the Manager.
Knowledge, Skills and Abilities
- Degree in Life science, Nursing or Pharmacy or other health-related field or equivalent qualification with at least two (2) to five (5) years of relevant experience within a Canadian pharmaceutical environment.
- Good communication and writing skills
- Working knowledge of Argus application
- Strong knowledge of MS Office (Word, Excel, PowerPoint)
- Minimum of two years of PV experience in pharmaceutical industry
- Familiar with Health Canada regulations and ICH guidance
- Strong attention to detail
- Must possess the ability to work effectively in a fast-paced environment, and deal effectively with changing priorities
- Knowledge of the use of eCTD Software for preparing and filing submissions preferred.
- Strong organizational ability to maintain a complex and high volume of technical information up to date
- Ability to plan, coordinate and work effectively in a team-oriented environment.
- Fluency in French an asset.
***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections