Associate, Drug Safety

4 months ago

Brampton, Canada Taro Pharmaceuticals INC, Canada Full time

**Job purpose**

Assist in all pharmacovigilance activities at Taro Canada including Adverse Event (AE) management, Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and Signal Detection.

Support Taro business objectives by providing timely, balanced and comprehensive Medical Information on marketed products in order to promote safe, rational and effective use of Taro and TaroPharma products. Provide support and oversight in other related Drug Safety activities including Phamacovigilance Agreement and Product Quality.

**Duties and responsibilities**
- Perform intake, follow-up and data review of adverse event (AE) cases.
- Assess, document, medically evaluate and process 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.
- Submit expedited reports to Health Canada. Prepare submissions in eCTD format which involves full understanding of the use of Adobe Acrobat to create bookmarks and links.
- Exchange relevant adverse event, drug safety and pharmacovigilance material with Taro affiliates worldwide.
- Perform reconciliation with business partners and vendors 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.
- Handle product complaints related to adverse events.
- Provide medical information to customers related to English medical inquiries on Taro and TaroPharma products.
- Assist in Health Canada pharmacovigilance inspection in coordination with QA/QC department to ensure successful results.
- Assist in quality review for Taro and TaroPharma 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 Taro Sales Force as needed.
- Other PV duties as assigned.

**Qualifications**
- Degree in Life Science, Nursing, 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.
- Strong working knowledge of Health Canada’s current GVP guidelines.
- Experience with eCTD submissions and knowledge of GMP and QA/QC procedures preferred.
- Knowledge and 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.
- Proficiency with applicable computer software - Microsoft Office (Word, Excel and PowerPoint) and Adobe Acrobat and Document Management Systems.
- Excellent interpersonal, written and verbal communication skills.
- Ability to plan, coordinate and work effectively in a team-oriented environment.
- Fluency in French an asset.

**Working conditions**

Office based role.

**Physical requirements**

Hybrid role; Three days in office, two days work from home.

**Direct reports**

NA

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