Pharmacovigilance Quality Assurance Specialist

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Job Summary 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 cause 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 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 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 Minimum Qualifications University Degree or College Diploma in a related field or equivalent (University Degree in Health Sciences is preferred) 2+ years of experience with/in case management/program management experience and/or previous pharmaceutical brand management experience or equivalent, specific to oncology, neurology, or specialty drugs is considered an asset Key competencies Excellent communications skills, verbal and written in English Experience in the healthcare, pharmaceutical, o Pharmacovigilance Quality Assurance Specialist Insurance industry is an asset Strong computer skills using MS Office (Excel, Word) Highly organized with strong attention to detail Ability to apply critical thinking skills in order to resolve problems Proven ability to manage time, set priorities, and multi-task in order to meet various competing work deadlines Team-oriented, with the ability to work independently We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards.

This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations.

In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here. Our Base Pay Range for this position $56,800 - $75,700 McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages.

In light of these scams, please bear the following in mind: McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application. McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail.

Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates. McKesson job postings are posted on our career site: careers.mckesson.com . McKesson is an Equal Opportunity Employer McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category.

For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page. McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities.

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