Original job description
We are partnering with an established pharmaceutical company in the Greater Toronto Area to appoint a Pharmacovigilance Manager. This is a senior, hands-on leadership role reporting directly to the executive team, with ownership of the safety function across a growing marketed product portfolio.
Primary Functions:
• Provide pharmacovigilance expertise to support the pharmacovigilance team on the detection,assessment, processing, and reporting of all safety events.
• Ensure quality, validity, accuracy, and timely submission of initial and follow-up safety eventreports.
• Perform quality check (QC) of adverse events/product quality complaints and all other applicable source documents to ensure compliance with PV reporting requirements.
• Preparation and submission of reconciliation reports as per PV agreements with suppliers.• As required, manage activities related to source data verification.
• Assist in development and oversee implementation of required PV training and education for the applicable cross-functional teams, and subcontractors.
• Take a train-the-trainer approach and assist in delivering program-specific PV training, producttraining or reporting training to personnel and assist in annual retraining as mandated andrequired to meet the PV obligations.
• Initiate/Review/Complete Non-conformance Quality Events (QEs) to ensure compliance withrequirements and documented procedures.
• Lead PV activities and implementation for new program launches.
• Create or update pharmacovigilance-specific work instructions and process workflows.
• Review existing PV processes and identify opportunities for improvement, always ensuringcompliance and audit readiness.
• Monitor monthly PV KPIs and proactively highlight trends to internal stakeholders for promptsolutioning.
• Drive the agenda and lead PV meetings with pharmaceutical client (s), proactively discuss anyidentified trends, and provide solutions for continuous process improvements.
• Proactively identify potential risks or gaps and provide risk mitigation strategies.
• Provide input in RMP – Risk Management Plans• Take the lead in PV audit preparation and audit do’s and don’ts training for the program team. Support program-specific audits as needed.
• Assist with new PV proposals and business development initiatives while striving for operational efficiency & cost efficiency.
• Process Safety data according to applicable regulations, guidelines, Standard Operatingprocedures (SOPs) and product requirements.
• Perform Pharmacovigilance activities for all Mint marketed drug products and API molecule level including but not limited to, collecting, and tracking incoming Adverse Drug Reactions, medical inquiries and endpoint follow-up information. Prepare line listing for all the ADRs received.
• Determine iniNal/update status of incoming events, MEDRA code ADRs and Products, writenarratives, literature-related activities, Quality review, assisting with reconciliation, case closurerelated activities, coordinating translations. Creating, maintaining, and tracking cases asapplicable.
• Assess Safety data for reportability to relevant authorities, track reportable cases and report toregulatory authorities, ethics committees, institutional review boards, investigators, oversightgroups per legislation, within timelines and in a format compatible to meet requirements as perproject. Liaise with relevant stakeholders to facilitate expedited reporting.
• Review and approve PSURs for all Mint drug products within the timeline required by HealthCanada Guidance.
• Perform signal detection and inform Regulatory Affairs Department if required.
• Contribute knowledge and expertise to or lead assigned deliverables in the field of SafetyPublishing, Risk Management, Safety Surveillance and Medical Information or other service linesas appropriate.
• Ensure meeting quality, productivity, and delivery standards per project requirements.
• Ensure compliance with all marketed product-related processes and activities.
• Maintain Pharmacovigilance agreements with all the vendors as required by Health Canada. Perform reconciliation as per Pharmacovigilance Agreements with all the vendors.
• Set up and maintain project files, standard templates, electronic forms, databases, and workflow as per project requirement.
• 100% compliance with all people practices and processes and record keeping.
Qualifications.
• Qualified Health Care Professional – in good standing as a professional medical, nursing,pharmacist, or other health care professional and entitled to provide health careunder the laws of the jurisdiction in which the person is located and who have the appropriatehealth care education and therapeutic experience or other individuals retained by the MAH whohave the appropriate health care education and therapeutic experience. Relevant work experience will be an asset.
• Minimum 5-10 years of overall PV experience or related healthcare working experience (inMedical Information, Drug Safety-Pharmacovigilance, Medical Affairs, Regulatory Affairs, ClinicalTrials or Healthcare Services environment).
• Experience in handling GVP Audits, CAPA generation and completion.
• Knowledge of current Pharma PV practices and PV quality standards is an asset.
• Bilingual (English/French) is an asset.
• Knowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed HealthProducts, Health Canada GVP (Good Pharmacovigilance Practices), Canada Vigilance-MedEffectProgram, GDP (Good Documentation Practices), GCP (Good Clinical Practices), Global PV Regulations, ICH Guidelines and Pharmacovigilance Auditing.
• Strong knowledge of drug benefit/risk profile, various disease states, internal medicine,physiology, toxicology, and pharmacology will be considered an asset.
General Requirements• Excellent written, verbal communication and facilitation skills.• Excellent organizational & critical thinking skills.• Strong and proven attention to detail.• Ability to work with strict timelines and handle multiple priorities.• Flexible, adaptable, and able to work under pressure and convey a sense of urgency.
• Demonstrated initiative and accountability, and able to work under minimal supervision.
• Possess a customer service mindset and skills (internally and externally).
• Ability to handle challenging conversations.
• Team leader and a team player with the ability to function in a multidisciplinary environment and promote collaboration.
• Proven leadership skills including coaching and mentoring peers and colleagues.
• Ability to lead people and invest in their growth and development.
• Proficiency with basic computer skills, Excel, PowerPoint, reporting tools etc.
• Prior experience with pharmacovigilance reporting software, safety databases & applicationsan asset.
• Ability to work flexible hours including but not limited to extended business hours, weekends or public holidays.
