Regional Manager (Canada, USA), Pharmacovigilance & Medical Information Job in Montreal Recruiting by Knight Therapeutics

About Knight
Knight Therapeutics is a pan-American (ex-US) specialty pharmaceutical company focused on acquiring, in licensing, out-licensing, marketing, and commercializing innovative prescription pharmaceuticals in Canada and Latin America. Knight owns Biotoscana Investments S.A., a pan-Latin American specialty pharmaceutical company. Knight Therapeutics shares trade on TSX under the symbol GUD. Headquartered in Montreal, Knight has nearly 700 employees globally.Position Summary
The Manager oversees the Canada and USA Pharmacovigilance and Medical information activities. The Manager provides direction to an external supplier, Senior Analysts and student(s). The Manager ensures that the frontline personnel have the necessary training and resources to appropriately meet the customer needs and expectations.
The Manager works in close collaboration with the other Knight departments (medical, regulatory affairs, quality assurance, marketing, access, etc.)
The Manager ensures compliance of the pharmacovigilance activities with laws and regulations and Knight procedures in Canada and the USA.
Ensure operationalization of the medical information activities in Canada and the USA.
This position is based in Montréal; French/English bilingualism, both written and oral, is required.Responsibilities
Supervise and support the Pharmacovigilance activities performed by the external supplier/senior analysts:
• Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, Knight procedures and in-licensing partner requirements and timelines. Code the ICSR with MedDRA. Protect personal data. Perform ICSR follow-up and reconciliation activities.
• Adapt and review periodic and/or annual safety reports and submit to Health Authorities as per the applicable regulations.
• Adapt and review Risk Management Plans and submit to Health Authorities as per the applicable regulations. Once approved, implement and follow-up on additional activities (such as distribution of materials to Health professional and collection of data). Ensure all the local/regional requirements are met.
• Liaise efficiently with external service providers, as applicable.
• Prepare, review and ensure compliance of pharmacovigilance agreements with external suppliers and/or local in-licensing partners, as applicable.
• Review pharmacovigilance clauses in clinical trial protocols, patient support programs, market research, etc.
• Conduct Good Pharmacovigilance Practice (GVP) audits, as applicable.
• Participate to audits, including self-audits, and inspections and address any questions from the Health Authorities and partners. Implement correction action plans when required.
Supervise and support the Medical Information activities performed by the supplier and senior analyst:
• Liaise efficiently with medical information external provider
• Customize the frequent asked questions (FAQs) and/or standard response letters (SRLs) for Knight products as per local requirements.
• Address medical information questions from HCPs, patients, customers or internal stakeholders.
• Ensure that any adverse events, special situations or off-label uses are collected and reported to Health Authorities as per the applicable laws and regulations.
• Collect Product Quality Complaints and share with Quality department.
• Participate and interact with medical colleagues and cross-functional team members to ensure sharing of insights and data. Assists in the management of product issues/crisis.
• Proactively seek and take appropriate action to advance new solutions to improve medical information processes.
• Support the following Medical Information & Pharmacovigilance Activities:
• Develop Medical Information and Pharmacovigilance standard operating procedures (SOPs) and working instruction processes. Maintains compliance with regional training requirements on standard operating procedures (SOPs) and working instructions.
• Provide expertise and recommendations for product safety labeling updates.
• Facilitate the development and maintenance of documents to improve access.
• Participate in local and/or regional projects/initiatives by providing strategic input and insights as needed.Characteristics of a Good Candidate
Leadership:Leads the team strategy, builds a common vision and ensures efficient execution.
Organisational Skills:Have good analytical skills with high-level attention to detail and commitment to accuracy and depth. The manager is able to handle multiple projects at a time.
Teamwork/Negotiation skills:Have good interpersonal skills and demonstrates flexible and adaptable communications capabilities with partners inside and outside the company. Be able to effectively function in a fast-paced, people oriented, team environment.
Autonomy/Problem Solving:Have the ability to identify ways to improve efficiencies and bring it forward in a timely manner.
Agility/Dealing with Ambiguity:Demonstrate adaptability in situations involving changes and an ability to evaluate and adapt based on stakeholders requirements.Required:
Healthcare Professionals: Nurse, Pharmacist or PhysicianMinimum of 2 years in people management and/or vendor management
Minimum of 5 years in Pharmacovigilance/Medical Information.
Experience in self-audits, inspections with Health Canada and FDA.Asset:
Experience in Regulatory Affairs and/or Quality Assurance
Excellent Scientific Knowledge
Excellent communication skills; written and oral French and English
Strong knowledge of Microsoft Office SuiteBenefits of working at Knight:
· Competitive salary and bonus plan
· Employee share purchase plan
· Flexible group insurance plan
· Registered retirement savings planAs illustrated in the description of the tasks, it requires, in particular, to communicate, verbally and in writing, with the other team members located across Canada as well as Latin America as well as customers across Canada. Following an assessment, we have therefore determined that the performance of these tasks requires the knowledge of the English language, in addition to the knowledge of the French language (written and spoken). We have also determined that the English knowledge already required from other employees is insufficient for the performance of the duties requiring the knowledge of EnglishPlease send your CV and cover letter to [email protected]
Only selected candidates will be contacted.