Pharmacovigilance Manager

Primary Functions:

• Provide Pharmacovigilance expertise to support 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 event reports.

• 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 train the trainer approach and assist in delivering program specific PV training, product training or reporting training to personnel and assist in annual retraining as mandated and required to meet the PV obligations.

• Initiate/Review/Complete Non-conformance Quality Events (QEs) to ensure compliance with requirements 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 ensuring compliance and audit readiness.

• Monitor monthly PV KPIs and proactively highlights trends to internal stakeholders for prompt solutioning.

• Drive the agenda and lead PV meetings with pharmaceutical client (s), proactively discuss any identified 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 operating efficiency & cost efficiency.

• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (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 end point follow up information. Prepare line listing for all the ADRs received.

• Determine initial/update status of incoming events, MEDRA code ADRs and Products, write

narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations. Creating, maintaining, and tracking cases as applicable.

• Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting.

• Review and approve PSURs for all drug product within the timeline required by Health Canada Guidance.

• Perform signal detection and inform Regulatory Affairs Department if required.

• Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines

as appropriate.

• Ensure to meet quality, productivity, and delivery standards per project requirements.

• Ensure compliance to all marketed product related processes and activities.

• Maintain Pharmacovigilance agreement 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 towards all people practices and processes and record keeping.

Qualifications

• Qualified Health Care Professional – good standing of a professional medical, nursing, pharmacist,

or other health care practitioner association and entitled to provide health care under the laws of the jurisdiction in which the person is located and who have the appropriate health care education

and therapeutic expertise or other individuals retained by the MAH who have the appropriate health care education and therapeutic expertise. Relevant work experience will be an asset.

• Minimum 5-10 years of overall PV experience or related healthcare working experience (in Medical Information, Drug Safety-Pharmacovigilance, Medical Affairs, Regulatory Affairs, Clinical

Trials or Healthcare Services environment).

• Experience in handling GVP Audits, CAPA generation and completion.

• Knowledge of current Pharma PV practices and PV quality standards an asset.

• Bilingual (English/French) is an asset.

• Knowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed Health Products, Health Canada GVP (Good Pharmacovigilance Practices), Canada Vigilance-MedEffect

Program, 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 be able to work under minimal supervision.

• Possess customer service mindset and skills (internally and externally).

• Ability to handle challenging conversations.

• Team leader and a team player with ability to function in a multi-disciplinary 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 a Pharmacovigilance reporting software, safety databases & applications an asset.

• Ability to work flexible hours including but not limited to extended business hours, weekends or public holidays.