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    Senior Manager, Drug Safety - Oakville, ON, Canada - Xcenda, LLC

    Xcenda, LLC
    Xcenda, LLC Oakville, ON, Canada

    2 weeks ago

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    Description

    Senior Manager, Drug Safety page is loaded

    Senior Manager, Drug Safety

    Apply locations Oakville, ON Remote, ON time type Full time posted on Posted Yesterday job requisition id R241771

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today

    What you will be doing

    PRIMARY DUTIES AND RESPONSIBILITIES:

    Regulatory Responsibilities:

    • 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.

    Departmental and Staff Responsibilities:

    • 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;
    Operational Responsibilities:

    • 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.

    What your background should look like

    EXPERIENCE AND EDUCATIONAL REQUIREMENTS:


    • 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

    MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:


    • 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

    What Cencora offers

    We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.

    To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

    For details, visit amerisourcebergen

    .

    Schedule

    Full time

    Affiliated Companies:

    Affiliated Companies: Innomar Strategies

    Equal Employment Opportunity

    Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

    The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

    AmerisourceBergen is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

    Accessibility Policy

    AmerisourceBergen is committed to fair and accessible employment practices. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.

    About Us

    Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them.

    We're a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.

    #J-18808-Ljbffr
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