Manager, Medical Information and Pharmacovigilance

Location:

At Shoppers Drug Mart were innovating health and wellness in Canada. From prescriptions to walk-in clinics and a beloved loyalty program were caring and supporting our customers in new ways every day.
With more than 1300 locally owned and operated stores from coast to coast the Shoppers Drug Mart network is more than a great place to shop its a great place to work. Were 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. The Leader provides coaching and support to consultants 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 an ability to apply concepts and theories to improve functions or units.

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 regarding pharmacovigilance processes and compliance requirements

Maintaining patient safety first while recognizing the importance of good business decisions

Computer skills working with PV databases produce effective reports documents spreadsheets and presentations.

Communicates with clarity verbally to conduct personnel training and in oneonone or group situations or over the telephone.

Communicates well in writing by composing clear documents

Able to work with minimal of supervision.

Proficiency in all Microsoft Office applications (especially Excel Word and PowerPoint)

Why work at Shoppers Drug Mart

Acting as consultants supporting internal customers and the Associate-Owners you will get experience unique to the retail industry while working for an award-winning national brand. Benefit from a purchase discount program competitive pay and online learning through Academy.

Take ownership of your work and find more ways to care about your work co-workers customers and community.

How Youll Succeed:

At Shoppers Drug Mart Inc. we seek great people to continually strengthen our culture. We believe great people model our values are authentic build trust and make connections.

If that sounds like you and you are open-minded responsive to change and up to the challenges provided in a fast-paced retail environment apply today.

Employment Type:

Type of Role:

Shoppers Drug Mart Inc. recognizes Canadas diversity as a source of national pride and strength. We have made it a priority to reflect our nations evolving diversity in the products we sell the people we hire and the culture we create in our organization. Accommodation is available upon request for applicants with disabilities in the recruitment and assessment process and when hired.

In addition we believe that compliance with laws is about doing the right thing. Upholding the law is part of our Code of Conduct it reinforces what our customers and stakeholders expect of us.

Please Note: If you have Employee Self Service (ESS) on Workday apply to this job via the Workday application.

#EN