CSH Canada

CSH Canada

• Location: REMOTE - Laval, QC

About the job

Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.

We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet. That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core. Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.

This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers. We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification. Join us on our mission. Health. In your hands.

Reporting to the North America PV Head, the Country Safety Head, Canada position contributes to establishing the benefit-risk profile of Sanofi Consumer Health Inc. products in close collaboration with corporate and local teams, while maintaining compliance with Corporate and Canadian regulatory safety requirements. The incumbent contributes to ensure evidence-based and accurate medical information on Sanofi Consumer Health Inc. products is provided to healthcare professionals, consumers, and internal clients in a timely manner and in accordance with Canadian and Global Medical Information good scientific practices.

This position is responsible for Canadian and foreign case handling activities, as well as leading the activities in one or more of the following areas: risk management, quality system, process optimization, training, compliance, Pharmacovigilance (PV) systems, safety data exchange agreements, management of PV requirements in commercial projects, local safety surveillance, inspection readiness, monitoring of emerging Canadian PV regulatory requirements, crisis management.

This position also supports the Medical Information Contact Center (MICC) under external supplier responsibility. Develop and maintain Canadian product scientific response documents. Contribute to launch readiness activities for new products.

Main Responsibilities:

Pharmacovigilance responsibilities:

• Contribute to the PV activities for Sanofi Consumer Health Inc.
• Process domestic drug and medical device individual case safety reports (ICSRs) for marketed and non-marketed products according to Corporate and Canadian requirements.
• Evaluate domestic and foreign ICSRs (marketed and non-marketed drugs and medical devices) for submission to Health Canada according to Canadian regulations and within prescribed timelines.
• Handle safety related queries originating from all sources including crisis situations, product Alerts, and urgent Health Canada requests.
• Provide Pharmacovigilance expertise to internal partners.
• Contribute to brand development throughout the product lifecycle, via participation in cross-functional teams and via risk management initiatives.
• Monitor and oversee external vendors (including PV service provider, and external call centers) and internal partners for compliance with PV obligations.
• Provide medical evaluation for relevant domestic ICSRs.
• Organize and complete local safety surveillance activities according to Corporate and Canadian requirements.
• Provide local medical review of aggregate safety data.
• Coordinate preparation, maintenance, and submission of periodic safety update reports as per corporate and Canadian requirements.
• Prepare local periodic safety reports in collaboration with GPV.
• Contribute to the development and implementation of Global information systems supporting local PV activities.
• Evaluate and implement IS tools supporting local PV documentation and training activities in a validated environment.
• In partnership with GPV, ensure ongoing smooth functioning of an electronic submission process for ICSRs in accordance with Health Canada requirements and ICH E2B.
• Contribute to the implementation of relevant Global risk management activities locally.
• Develop local risk management strategies in close partnership with GPV and local teams, and in accordance with Canadian requirements.
• Ensure PV contribution to brand development throughout the product lifecycle, via participation in cross-functional teams and via risk management initiatives.
• Administer a training program for other PV staff on various subjects including Pharmacovigilance topics, SOPs (Standard Operating Procedures), products, and therapeutics.
• Administer a training program for all Sanofi employees and external partners (including the external call center) on adverse event reporting responsibilities/procedures.
• Organize a local quality system (SOPs) supporting PV activities.
• Optimize Pharmacovigilance procedures as well as all inter-departmental procedures affecting Pharmacovigilance.
• Develop, negotiate, and maintain safety data exchange agreements to meet corporate and Canadian regulatory PV requirements.
• Monitor compliance with adverse event reporting obligations within the PV department, other Sanofi departments as well as for external partners (including the external call center).
• Manage local PV deviations and compliance metrics generation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation and related tracking activities (ICSRs/ PSRs/HA queries)
• Warrant inspection readiness of the local PV system (auditable trail of all PV activities performed locally is maintained and readily available) with key stakeholders (i.e. Quality, Medical and Regulatory)
• Complete in timely manner audit and inspection observations in close interaction with global/local functions
• Ensure PV involved in and review of relevant safety sections of local documents, owned by other functions, such as labeling, contracts with third parties and local study protocols
• Ensure appropriate implementation and monitoring of PV requirements for local programs (e.g. Market Research), and company sponsored digital media
• Ensure local scientific/medical literature screening in compliance with Canadian regulatory and global requirements
• Participate in the local business continuity plan for PV
• Organize PV paper and electronic filing and archiving system as per Good Documentation Practices (GDPs) and according to corporate and Canadian requirements.

Medical Information responsibilities:

• Ensure quality of the information provided to our customers by supporting and monitoring MICC external supplier who is providing just in time evidence-based information and scientific expertise on Sanofi products.
• Provide guidance to MICC external supplier in a timely fashion on day-to-day requests within assigned therapeutic areas. This includes scientific response documents for verbal and written frequently asked questions, as well as response to ad hoc enquiries.
• Handle escalated enquiries.
• Provide support to MICC external supplier for primary intake of adverse events and product complaints, in collaboration with Pharmacovigilance and Quality Assurance teams.
• Perform quality control of MICC external supplier.
• Provide regular feedback/training to MICC external supplier to optimize Medical Information services.
• Contribute to the development, review, and update of local scientific response documents such as FAQs/Q&As, letters and technical sheets for use in verbal and written responses.
• Contribute to literature reviews.
• Maintain strong relations with Canadian and Global Medical Information teams to optimize sharing of product information.
• Ensure Medical Information materials are compliant with Canadian and Global Medical Information good scientific practices.
• Contribute to product launch readiness within the assigned therapeutic areas.
• Participate in the development of specific technical/medical responses or analysis to specific situations such as product discontinuation, media attention, crisis situations and responses to Health Canada or other organizations within the assigned therapeutic areas.
• Analyze and share customer insights with commercial and field teams to meet customer needs.
• Deliver training on Medical Information services and processes for commercial and field teams.
• Supports, contributes, organizes, and/or manages HealthCare Professional (HCP) Events and Engagements (Sanofi Events or Third Party Events) in accordance to Internal Sanofi Consumer Health Inc. Policy Requirements.

About you

• Education: Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master's Degree
• Experience: 5 years’ experience in the pharmaceutical industry or in a relevant Pharmacovigilance setting preferred. Previous in-depth experience of pharmaceutical medical information processes is necessary. Some experience in hospital, community pharmacy or in a drug information center would be an asset
• Experience in designing and conducting literature searches.
• Languages: French: Excellent oral and written communication skills. English level required: Advanced oral and written communication skills.