Pharmacovigilance Quality Assurance Specialist

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.

The Pharmacovigilance Quality Assurance Specialist is an integral part of the Pharmacovigilance team responsible for providing ongoing support to aid the daily business functions of the organization.

**Specific Responsibilities**
- Identify, author, track, and manage Pharmacovigilance deviation and privacy incident reports
- Conduct Pharmacovigilance deviation investigations
- Support in the identification of root causes and corrective and preventative actions
- Ensure corrective and preventative actions are completed in time by relevant stakeholders
- Update program documentation as required by the client, including program organizational charts
- Produce client-facing reports on Program’s compliance and effectiveness and present data to the Client in a professional, organized, and constructive manner
- Evaluate work processes and documentation to ensure they meet manufacturer compliance requirements and fully respond to deviation root causes
- Lead the training of new CAPA processes to ensure full understanding by Program stakeholders
- Instructor-led live Safety training coordination
- Manage client-issued Pharmacovigilance training and training records
- Provide support during audits, as required
- PV Reconciliations (Daily/Monthly/Quarterly)
- Main POC for PSP teams on matters related to AE reporting

**Section**
**B General Responsibilities**
- Assist in the development of new work and processes in response to identified Root Causes and in pursuit of robust Corrective and Preventative Actions. Identify and implement metrics to evaluate the effectiveness of process improvements

**Section**
**C**
**Minimum Qualifications
- Degree or equivalent and typically requires 4+ years of relevant experience.

**Section**
**D**
**Additional Qualifications
- Preferred University Degree in Health SciencesUniversity Degree or College Diploma in a related field or equivalent to five years of case management/program management experience and/or previous pharmaceutical brand management experience or equivalent, specific to oncology, neurology, or specialty drugs is an asset
- Excellent communications skills, verbal and written in English experience in the healthcare, pharmaceutical, or insurance industry is an asset.
- Strong computer skills using MS Office (Excel, Word)
- Team-oriented, with the ability to work independently

Career Level - IC - Professional - P3

At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at McKesson, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

**Our Base Pay Range for this position**

$69,700 - $116,100

**McKesson is an Equal Opportunity employer.**

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