About Miravo Healthcare:
Miravo Healthcare is a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products. The Company’s products target several therapeutic areas, including pain, allergy, neurology and dermatology. Miravo’s head office is located in Mississauga, Ontario, Canada, the international operations are located in Dublin, Ireland and its manufacturing facility is located in Varennes, Québec, Canada.
The Senior Manager, Pharmacovigilance reports to and collaborates very closely with the Sr. Director, Global Regulatory Affairs & Pharmacovigilance to manage the pharmacovigilance (PV) processes at Miravo. The position requires an understanding of the regulatory framework in Canada, EU and USA. It requires an experienced and confident manager who can collaborate with multiple stakeholders internally and with the vendor(s) to ensure compliance and high-quality standards. The individual in this position must be able to manage multiple tasks at once and prioritize completing requests or projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Responsible for oversight of the PV operational and case management providers activities for safety reporting including the collection, processing, and reporting/submission of safety information for all products in accordance with all applicable regulatory requirements, Good Pharmacovigilance practices (GVP) and internal operating procedures (e.g., SOPs).
- Conduct due diligence assessments on assigned projects.
- Review and evaluate PV vendor(s) performance and quality and generate performance and compliance metrics and monitor for trends or possible improvements.
- Participate in the development and maintenance of PV System policies, SOPs, forms, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.
- Conduct with Quality and as required audits of various partners and providers
- The position is responsible for ensuring that aggregate safety reports (Annual Safety Reports, PSURs) and risk management plans (RMPs) if applicable are written and maintained and ensures escalation of safety related issues and potential trends and or signals arising from review of post marketed safety data.
- Responsible for the AE training program at Miravo to ensure employees are aware of AE reporting requirements.
- Contribute to development and maintenance of Safety Data Exchange Agreements (SDEAs) and PV agreements with partners, vendors, and other third-parties.
- Collaborate with internal teams to prepare for Regulatory Authority inspections and in relevant internal/external audits and contribute to safety requests from Regulatory Authorities.
- Review new or updated PV regulations for modifications to internal procedures or changes to the agreements with vendors or partners.
- Other duties as assigned.
REQUIRED EDUCATION AND EXPERIENCE :
- Bachelor’s Degree or equivalent in scientific field, Healthcare professional degree preferred (PharmD, RPh, RN)
- Excellent understanding of PV regulatory environment with working knowledge of Health Canada, FDA, EMA and ICH regulations, Guidance, best practices, and Good Pharmacovigilance Practices (GVP)
- Working knowledge of safety databases, electronic data capture (EDC) systems, and electronic document management systems
- Experience in due diligence assessments
- Working knowledge of MedDRA coding
- Ability to travel up to 10%, as needed
ADDITIONAL SKILLS, KNOWLEDGE AND/OR ABILITIES:
- Minimum of seven years of experience within pharmacovigilance highly preferred; other experience may be considered
- Demonstrated ability to review documents critically and provide clear feedback on required changes as well as identify trends or inconsistencies for improvement
- Demonstrated success in initiating and managing partnerships with external vendors
- Demonstrated successful management of complex projects within the scope of this position
- Requires a high level of initiative and independence
- Must have excellent written and oral communication skills, resourcefulness and personal organization skills
- Computer literacy with proficiency in Microsoft Word, Excel, PowerPoint
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. / Avertissement : Les énoncés ci-dessus visent à décrire la nature générale et le niveau de travail effectué par les employés affectés à ce poste. Il ne s’agit pas d’une liste exhaustive de toutes les fonctions, responsabilités et qualifications. La direction se réserve le droit de changer ou de modifier les tâches au besoin