Are you looking to make a difference in a patient’s life?  At AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference.  As an organization, we are united in our responsibility to create healthier futures. Join us and Apply today!

What you will be doing

Reporting to the VP, Quality, Regulatory and Safety (QRS), the Senior Director, Pharmacovigilance and Medical Information is responsible for all pharmacovigilance services within the Pharmacovigilance unit (APV).  They will participate as a member of the management team to direct and lead a Pharmacovigilance Team.  They will be responsible for handling all Pharmacovigilance activities for Innomar clients, including those associated with Patient Support Programs (PSP), the development of Individual Clinic Safety Reports (ICSRs), MedDRA Coding, the determination of ‘relatedness’ as defined in Food and Drug Regulations and Guidelines, the determination of ‘severity’ as defined in Food and Drug Regulations and Guidelines, reporting required adverse reactions to Health Canada and/or the Food and Drug Administration, the development of integrated reports and other associated documents.  They will function as the key client contact related to Pharmacovigilance and Medical Information. The Senior Director, Pharmacovigilance and Medical Information will oversee a team of APV managers and associates who are either home based or based at Oakville and VSL locations.

PRIMARY DUTIES AND RESPONSIBILITIES:

Participates as a member of the Quality/Regulatory/Safety (QRS) management team to direct and manage the affairs of the company.

Leads the Pharmacovigilance group, which will manage all adverse event (AE) reporting functions, including full service Pharmacovigilance programs and services (e.g. PSUR development//Signal Detection & Trending/ Literature searches & reviews, Risk Management Programs, etc), their reporting and compliance protocols including development of SOPs, and Work Instructions. This includes liaising with Directors & Managers in other units to ensure optimal, effective and accurate management of PV related activities;

Leads the development and completion of client specific pharmacovigilance agreements (SDEA/MSAs), Scope of Work (SOWs), and Pharmacovigilance Proposals in collaboration with other members of the cross functional team (NBD, Programs, IT, etc.);

Responsible to develop and maintain Pharmacovigilance SOPs that will be based on the Food and Drug

Regulations and Guidelines from Health Canada for Canada and the Food Drug and Cosmetic Act and Guidelines from the Food and Drug Administration (FDA) for the US;

Oversees, organizes and maintains the structure and objectives of the department. Lead the training and development of assigned APV Managers and their Direct reports on the assigned PV programs. Ensures development and implementation of training plan including customer specific SOPs & WIs for each program;

Responsible for the integration of PV databases within the workflow.

Oversee Medical Information and related activities to support Innomar services in this area.

Leads, motivates, trains and retains an efficient, knowledgeable, and effective staff. Leads by example, to create strong team dynamics that result in successful, creative and innovative project outcomes;

Participates in strategic and tactical planning sessions; Identifies / maximizes market opportunities (target activities) and develops strategic and tactical plans to enhance performance and continuously achieve/surpass planned metrics & KPIs; Assists to prepare reports on unit operational plans including: strategic, tactical, budgetary, utilization and profitability of unit operations and plan and implement processes optimization plans;

Assists with the budget to plan; develop and implement departmental, strategic, and growth strategy plans to achieve sustainable earnings and revenue growth and to support cost reduction initiatives;

On-going client management, including strategic & tactical input to support PV reporting as per Health Canada /FDA guidelines;

Ongoing medical advisory responsibility to programs and nursing/pharmacy teams at Innomar as required;

Builds and maintains working relationships and networks that help to profile the companies services and capabilities and build brand recognition through client communication, management and relationship building;

Participates as a member of the management team at P2P meetings; monitors and provides ongoing communications of departmental activity;

Provides leadership and support to APV team to ensure solid growth and customer service to all clients.

The Senior Director, Pharmacovigilance will also be assigned other duties and tasks as required from time to time.

What your background should look like 

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

MSc(Pharm) or Pharm D; MD or Nursing credentials or other credentials with a healthcare background, or equivalent experience;

10+ years of related experience in Pharmacovigilance;

Minimum 10 years management experience;

Minimum 10 years in a Medical or related background;

Bilingual: English/French preferred;

Executive project and client management skills;

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

Advanced knowledge of Pharmacovigilance requirements

Strong business and financial acumen

Strong analytical and mathematical skills

Ability to communicate effectively both orally and in writing

Effective interpersonal, team management, and leadership skills

Effective organizational skills; attention to detail

Ability to consistently meet deadlines

Excellent problem-solving skills; ability to resolve issues effectively and efficiently

Knowledge of Microsoft Word, Excel, PowerPoint and other Office Programs

As of October 18, 2021, AmerisourceBergen requires all Canadian team members to be fully vaccinated and show proof of completed vaccine status at time of hire. If you cannot receive the COVID-19 vaccine due to a qualifying medical condition or sincerely held religious belief you will be required to follow AmerisourceBergen’s policy and process to apply for an exemption/accommodation. 

What AmerisourceBergen offers

We offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.

Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.

Schedule :Full time

Equal Employment Opportunity

AmerisourceBergen 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.

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