Manager, Medical Information

3 weeks ago

Toronto, Canada Sanis Full time

**Location**:
243 Consumers Road, Toronto, Ontario, M2J 4W8

At Shoppers Drug Mart, we’re innovating health and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we’re caring and supporting our customers in new ways every day.
With more than 1,300 locally owned and operated stores from coast to coast, the Shoppers Drug Mart network is more than a great place to shop, it’s a great place to work. We’re committed to building our talented team who champion collaboration, kindness and inclusivity. Join our team, and help recognize a healthy future for your career and for all Canadians.

**Why this role is important?**

**Manager, Medical Information and Pharmacovigilance**

**Sanis Health Inc**

Reporting to the Director, Quality Assurance, the Manager, Medical Information and Pharmacovigilance is responsible for managing pharmacovigilance, drug safety and medical information of Sanis products.

**Duties and Responsibilities**:
The Manager will work with manufacturing partners and internal stakeholders to ensure that all Health Canada pharmacovigilance regulatory requirements and GVPs are understood and met. This position has 1-3 direct reports. Leader provides coaching and support to team and other peer and management team members.

The scope of the role encompasses broad functions such as preparation of Annual Summary Reports, Canada Vigilance Database Screening, Data Entry, Medical review, and submission to Health Canada of Individual Case Safety Reports for the Canadian Market.
- Develop and implement strategy for completing required pharmacovigilance activities in compliance with Health Canada pharmacovigilance requirements and GVPs
- Provide high quality and timely information to requests for medical information
- Maintain a log of the Medical Information requests and responses
- Ensure product complaints are triaged and forwarded to the Quality Department
- Ensure Adverse Events are processed and reported as required
- Ensure Annual Summary Reports are prepared in a timely manner
- Ensure Individual Case Safety Reports (ICSRs) are processed in a timely manner and entered in the electronic database
- Ensure ICSR reconciliation is completed
- Ensure Canada Vigilance Screening is completed as required
- Ensure screening of local scientific & medical publications for ICSRs and aggregate safety reports
- Maintain and update pharmacovigilance SOPs as required.
- Maintain and update pharmacovigilance agreements as required.
- Coordinate Vendor audits as required.
- Perform all work in accordance with established Health Canada pharmacovigilance requirements, GVPs and Sanis Health Inc. internal procedures
- Assigned pharmacovigilance tasks to department team members as required.

**Skills and Experience**:
This position requires an advanced level of initiative and judgment to organize and prioritize tasks, workload, and projects. A strong ability to influence while maintaining courtesy, tact and diplomacy is required in dealing with colleagues in every day working relationships.
- Minimum 5+ years working in GVP/GMP pharmaceutical industry in Pharmacovigilance
- Must have a Bachelor of Science (or Canadian Equivalent); Preferred - Bachelor of Science in Pharmacy
- Fully Bilingual (French/English), oral and written.
- Superior attention to accuracy, detail, and deadlines.
- Ability to work under strict deadlines and changing priorities with limited supervision
- Understanding of existing regulations and guidance.
- Strong understanding and sound interpretation of Health Canada GVP/GMP and other related guidelines.
- Experience with working with PV Databases
- Excellent command of MS office tools
- Pharmacovigilance Auditor Certification and audit experience
- Regulatory Affairs, Quality Assurance, Supply Chain and Logistics experience, is an asset
- Strong interpersonal skills with the ability to build strong working relationships with key stakeholders.
- Risk-based approach decision making and business acumen

**Additional Skills and Experience**:

- Requires specialized interpersonal skills to resolve situations with colleagues where there may be some level of conflict, stress, or uncertainty.
- Provides solutions by using imaginative approaches where constructive and critical thinking and innovation are required.
- Utilizes decision making skills to achieve specific organizational objectives with consideration given to their impact on other work groups.
- Adaptable to set and prioritize work with varying exceptions. Able to work with diverse personalities and styles.
- Advanced understanding of Pharmacovigilance policies and procedures
- Ability to handle sensitive issues requiring timely completion of documentation
- Strong knowledge of pharmacovigilance compliance and regulatory components, auditing skills, and quality systems
- Interpret Health Canada GVPs, GMPs and other guidelines and regulations, corporate policies/standards to determine enterprise position r

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