Compliance Program Quality and Controls Manager
U.S. Bank
Director, Pharmacovigilance and Medical Information
Recruiting.com
full-time
Posted on:
Origin: • 🇨🇦 Canada
Visit company websiteSalary
💰 CA$103,300 - CA$159,170 per year
Job Level
Lead
About the role
- Lead a team handling pharmacovigilance services including case processing and reporting to Health Authorities
- Oversee writing of aggregate reports, literature search and review, Health Canada database monitoring, signal detection, Risk Management Plan activities
- Lead team managing all Medical Information requests including a call centre, Standard and Complex Medical Information Requests, and communications with patients, healthcare professionals, and company personnel
- Manage client relationships and expectations, participate in client meetings, provide advice on pharmacovigilance and Medical Information topics, and follow-up on action items
- Develop and maintain SOPs and work instructions compliant with the Food and Drugs Act and Regulations and Health Canada guidelines
- Compile data for financial invoices monthly and monitor team performance; discuss recommendations with Senior Director
- Ensure overall client management to meet client KPIs and internal individual case submission compliance threshold of 99%
- Maintain audit- and inspection-ready team activities; collaborate internally and with clients for audits and inspections
- Review, comment on, and provide guidance on various reports
- Develop and maintain partnerships with decision-makers across departments to achieve business results
- Act as primary contact for clients, ensuring quality consistency and timely responses
- Identify client issues and develop strategies to successfully complete projects and enhance client satisfaction
- Present client services and training seminars as required
- Manage and develop staff to strengthen associates' knowledge and expertise in pharmacovigilance and Medical Information
- Provide technical expertise for maintenance of departmental databases and manage external service providers (e.g., ProQuest, MedDRA)
- Perform other related duties as assigned
Requirements
- Degree educated
- Healthcare professional, or extensive equivalent experience and related training
- 10 - 15 years’ pharmacovigilance experience
- 5 to 10 years’ experience in managing human resources
- Bilingual, Fluent in English and French preferred
- Excellent written and verbal communication skills including client presentations and training services
- Direct experience and working knowledge of a wide range of drug products
- Development and maintenance of work processes in line with customer needs and expectations
- Time management and multi-tasking skills
- Effective project management and people management skills
- Strong business and financial acumen
- Strong analytical and mathematical skills
- Effective interpersonal and leadership skills
- Effective organizational skills; attention to detail
- Ability to consistently meet deadlines
- Excellent problem-solving skills; ability to resolve issues effectively and efficiently
- Excellent presentation skills
- Knowledge of Microsoft Word, Excel, PowerPoint and other Office Programs
- Experience with databases and external service providers (e.g., ProQuest, MedDRA)
