Associate - Patient Safety Consultant

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

We are looking for a Canadian Pharmacovigilance / Patient Safety and Complaints expert to join our team. In this role you will be an integral part of the Lilly team in representing Safety and working with multiple stakeholders both internally and externally to ensure quality and compliance to both external and internal pharmacovigilance requirements. The Associate/Sr. Associate/ Manager responsibilities can vary depending on the needs and focus of the business and department.

This role is determined to be a flexible worker, where on-site presence in the Toronto office is expected to be 4-12 days per month, as determined by your manager and business needs.

**Responsibilities**:

- Ensure adherence to Good Vigilance Practices ( GVP) compliance to Health Canada requirements
- Maintain PV expertise and understanding of Canadian and international regulations and guidance, company standards and SOPs, including alignment internationally
- Maintain the local pharmacovigilance system, including the performance of the quality system and pharmacovigilance activities to promote, train, maintain and improve compliance with the legal requirements and relevant Good Vigilance Practices
- Understand the pharmacovigilance activities ( adverse event management, expedited and periodic reporting, PSURs, RMPs, Foreign Risk Notification)
- Provide PV and risk management expertise to internal partners and external customers
- Develop product expertise to assess seriousness of adverse events and product complaints and escalation of significant safety or compliance issues to local and global management
- Represent safety and complaints on projects and cross functional teams within the affiliate and on global teams, collaborating across Medical, Marketing teams, Sales, Clinical, Customer Relations, Regulatory, Quality Assurance, Patient Support Programs, Market Research/Social Medial teams
- Communicate and collaborate with Business Alliances, Vendors, Regulatory Agencies to ensure adherence to PV requirements and support pharmacovigilance agreements
- Lead any local actions that are required to manage a safety issue with Lilly products in collaboration with the responsible global and local teams, including development of regulatory communications related to safety issues
- Lead product Canadian Risk Management Plan (RMP) activities with Global Safety, Medical, Regulatory, Brand Teams and other business partners to provide leadership, design, development and updates to risk management strategies or programs, monitoring of effectiveness measures and adjustment to strategy, as required
- Support and strive for the inspection readiness and participate in affiliate inspections, audit and assessments.
- Ensure relevant safety standard operating procedures (SOPs) are well understood across the aligned affiliate, lead and provide clarification on local implementation

Basic Requirements:

- Bachelors of Science (Physics, Chemistry, Biology, Biochemistry, microbiology, physiology, anatomy, pharmacology, nursing). Preferred: Rph or Degree in the field of Medicine or Pharmacy or equivalent combination of education and related work experience.
- 4+ years of Health care or Pharmaceutical industry experience. Preferred: 2+ year PV experience (co-op experience is relevant)
- Fluently bilingual in both English and French
- Familiarity with medical terminology
- Knowledge of the related Health Canada PV and international regulations
- Effective communication skills to build strong relationships as part of cross functional team, including Medical Information, Regulatory Affairs, Quality, Customer Support and Medical
- Proficiency with Microsoft Office Word, Excel, PowerPoint and Adobe Acrobat, Safety Databases

Additional Skills/Preferences:

- Strong knowledge of quality systems Flexibility to adapt to changing priorities
- Supports a learning environment, open to suggestions for improvement
- Deals comfortably with ambiguity and uncertain risk.
- Acts consistently with Company ethics, obligations and local laws

Additional Information:
Travel as needed, 10%

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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