Senior Manager, Drug Safety

• Ensures effectiveness of AE reporting processes, to meet and exceed client expectations and governing PV regulations, primarily Health Canada/TPD;
• Works with Patient Support Program Managers, 3PL team members, and Innomar Quality Assurance & IT teams to ensure program compliance with client expectations, and required PV regulations;
• Monitors quality control practices, documents and identifies any trending errors/concerns and provides resolution;
• Ensures development and updating of SOPs and WIs for respective programs;
• Ensures SOP/Protocol adherence, and oversees PV related CAPA reporting
• Ensures completion and maintenance of training documents and all required reference documentation (product monographs, disease state descriptions, SOPs, etc).
• Assists and manages the Pharmacovigilance Specialist(s) to ensure regulatory reporting (CIOMS) for full service pharmacovigilance programs (as per contract), including severity and causality assessments
• Informing Pharmacovigilance Directors of regulations or Health Authorities guidance’s updates or changes, as well as participating to the impact evaluation, internal procedures associated changes and training.

• Responsible for the recruitment, training, coaching and performance management of team members, creating and promoting an environment of teamwork, empowerment, and engagement;
• Trains, motivates, and retains an efficient, knowledgeable, and effective staff;
• Identifies training needs based on monitoring, and leads refresher adverse event training as required and determined as necessary,;
• Works with HR and the training department to bring training opportunities to the team as deemed relevant;
• Ensures effective operations of all team members,
• Leads by example, to create strong team dynamics that result in successful, creative and innovative service offerings;
• Demonstrates commitment to APV organization and inspires / mentors fellow employees;
• Builds and maintains working relationships and networks that help to profile the company’s services and capabilities and increase industry and build brand recognition through client communication, management and relationship building;

• Working with the Associate Manager(s) Pharmacovigilance, monitors and provides adequate team coverage and work distribution (including weekends and holidays, as applicable);
• Monitors daily and on-going client reporting and project communications for completion, accuracy and timeliness;
• Works with relevant groups (IT, QA) to identify needs for modification of program database, pharmacovigilance database, protocols and current processes;
• Identifies process improvements, leads and participates in database upgrades and testing initiatives
• Participates in client consultations and working sessions in collaboration with the Director Pharmacovigilance, and provides input on proposals, including reviewing PV agreements, SDEAs, and SOWs ;
• Works with Director Pharmacovigilance, Quality Assurance, and Program Management to ensure department is audit ready;
• Ensures that corporate policies are followed and that reviews and audits of processes are implemented and documented according to company policy;
• Works with Director, Pharmacovigilance to ensure financial responsibilities and targets are met;
• Identifies areas for process improvements, evaluates for potential and oversees implementation;
• Supports complex and major departmental projects in all APV sub-teams (as examples, database improvements, electronic submissions etc.),
• Proposing innovative solutions to challenges, that are as much as possible applicable to many clients, and will improve the enlarged team efficiency.
• The Senior Manager may be requested to present at the upper management level, or key client meetings, or be requested to support the preparation of material for strategic meetings.
• On call availability for rotational statutory holiday coverage where required.
• Ensures high quality deliverables (internal and external) are completed on time
• The Senior Manager, Pharmacovigilance will also be assigned other duties and tasks as required from time to time.

• May be required to be on standby/ on call as part of this role.

• Bachelor degree in Healthcare or Science with a healthcare background, or equivalent experience;
• HCP license (RN, RPN, Pharmacy) a requirement for select customer contracts for selected locations
• 7+ years of related experience in post-market drug development and or Pharmacovigilance including research and/or regulatory experience or a combination thereof
• Experience with project and people management;
• Related management experience and experience leading a large team;
• Experience in pharmacovigilance
• Experience in medical information, and clinical research is an asset;
• Bilingual: English/French preferred;
• Excellent organization, computer skills, and business planning expertise (including forecasting budgets, processes etc);
• Knowledge of Special Access Programs and Risk Management Programs

• Advanced knowledge of pharmacovigilance Industry in Canada & globally;
• Advanced knowledge of Pharmacovigilance industry including up to date knowledge of; GUI 0102, GVP, ICH GCP MHRA, Canadian Food and Drugs Act, and US FDA guidelines;
• Strong analytical, and logic skills with excellent problem-solving ability;
• Strong business and financial acumen;
• Superior organizational skills; high attention to detail and demonstrated ability to multi-task and prioritize required tasks;
• Strong work ethic, sense of responsibility, high level of attention to detail;
• Effective interpersonal and leadership skills
• Ability to consistently meet deadlines
• Extensive understanding and analytical thinking to suggest logical and reasonable solutions from both internal and client perspectives
• Excellent presentation skills
• Knowledge of Microsoft Word, Excel, PowerPoint and other MS Office Programs

Cencora