Patient Safety Lead

Job Description

As a Patient Safety Lead, you will lead pharmacovigilance activities as the primary and key internal and external point of contact in the affiliate for Patient Safety.

Your Key Responsibilities

Your responsibilities include, but not limited to:

• Build strong relationships with cross-functional stakeholders in Canada, including regulatory affairs, medical affairs, quality assurance, marketing and sales, clinical development and third-party pharmacovigilance vendors to ensure a robust pharmacovigilance system and inspection/audit readiness.
• Act as the pharmacovigilance single point of contact in Canada, internally and externally to the health authority, while ensuring safety information flows appropriately locally and globally.
• Oversee the activities of the pharmacovigilance third party vendors for Canadian related activities, including adverse event management, period reporting, pharmacovigilance agreements and local literature searches.
• Accountable for strategic negotiation and execution of local pharmacovigilance agreements.
• Support in the set-up of patient support, primary market research, and managed access programs and any other activities that may elicit adverse event and other safety relevant information by collaborating in the set-up of programs/projects and implementation of reporting pathways, including data reconciliation and source data verification.
• Oversee the implementation of local Risk Management Plan and associated additional Risk Minimization Measures.
• Lead and support local initiatives to identify gaps in safety and cross-functional related processes, remediate, and improve.
• Ensure that all local internal and external stakeholders are adequately trained from pharmacovigilance obligations and the methods to report adverse events.
• Monitor applicable compliance information for pharmacovigilance activities and investigate noncompliance in partnership with global patient safety organization and third-party pharmacovigilance vendors.
• Maintain audit/inspection readiness in cooperation with the third-party vendors, global patient safety, quality assurance and other applicable cross-functional teams and represent the patient safety team during these activities with partners and investigators.
• Responsible for people management and development of patient safety direct reports locally and remotely.
  
  

Essential Requirements

What you’ll bring to the role:

• Bachelor degree in Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or related field.
• Minimum 7 years experience in drug-safety and pharmacovigilance in Canada: PV-processes, covering compliance, databases, procedures, QA and training.
• Minimum 2 years experience in managing a team.
• Experience in pharmacovigilance audits and inspections.
• Extensive knowledge of Health Canada pharmacovigilance requirements and regulations.
• Fluency in oral and written French is mandatory. Due to the nature of our operations, oral and written fluency in English is required for regular communication with customers, partners, and/or colleagues, whether in Canada or internationally.
• Good knowledge with MS Office tools.
• Hybride position, must be able to come to our Boucherville office on weekly basis.
• Ability to solve complex regulatory issues and requirements.
• Proven ability to critically evaluate and integrate data from a broad range of areas/domains.
• Ability to effectively communicate and influence cross-functional stakeholders.
• Demonstrated track record to lead/work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.
• Demonstrated ability for innovative and big picture thinking.
• A can-do attitude with a solution oriented mind-set.
• Highly organized and strong leadership and willingness to develop others.
  
  

Desirable Requirements

• Experience working with a company at a global scale.
  
  

You’ll Receive

• A minimum of three weeks’ vacation.
• Paid time off in addition to your annual vacation and statutory holidays.
• Time back between Christmas and New Year’s Day with full pay.
• Group pension plan with substantial employer contributions.
• Generous and flexible group insurance coverage through our private plan.
• Employee and family assistance.
• Hybrid work formula offered.
• Telemedicine services.
• Parental leave – supplemental top-up payments up to 100% of base salary, regardless of gender or sexual orientation.
• Career enhancement and development, including learning, training and professional recognition opportunities.
  
  

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool

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