Regulatory Affairs PV internIreland, Remote Job ID JR0103697 Category Intern Post Date Jan. 05, 2024
McKesson Corporation (NYSE: MCK) is one of the biggest companies in the world, with revenues of $263.97 billion in 2022. McKesson is ranked 9th on the 2022 Fortune 500 list. McKesson was founded in 1833, and currently has 78,000+ employees globally. McKesson is an industry leader in:
• Pharmaceutical distribution in North America
• Medical-surgical distribution to alternate care sites
• Generics pharmaceutical distribution
• Business and clinical services for providers
• Healthcare technology solutions.
Based in Cork, Ireland, NorthStar Healthcare is a leading international supplier of generic pharmaceutical drugs and a wholly owned subsidiary of McKesson Corporation. McKesson Private Label (i.e. NorthStar, McKesson Corporation dba SKY Packaging and Strategic Sourcing Services, LLC) products are manufactured at established facilities that are registered with the U.S. Food and Drug Administration (FDA). McKesson Private Label generic drug products are manufactured in an efficient and cost-effective manner to generate increased savings for its diverse customer base in North America. Customers include:
• Independent Retail Pharmacy Owners across North America
• Long-Term Care Pharmacies
• National Retail Chains in North America
• McKesson Owned Pharmacies in North America and Europe.
The McKesson generics private label portfolio is broad and continues to meet the wide-ranging, ever-growing needs of its customers. Since launching its first drug in September 2007, NorthStar have grown to become a significant growth driver for McKesson and its global sourcing strategy. In 2020, responsibility was assumed for the Regulatory and Quality compliance for additional McKesson private Labels, McKesson Corporation dba SKY Packaging and Strategic Sourcing Services LLC.
The Regulatory Affairs M.Sc. student will play a key role in supporting the team achieve its business goals. NorthStar will support this individual during their placement so that they develop key skills and experience to support them in their future career development. Supporting the broader organisation, the individual will interact with McKesson Private Labels strategic partners as well as with the personnel within McKesson private label colleagues. The role involves provision of support in various elements of regulatory and pharmacovigilance compliance. The role will involve day to day support of various regulatory and pharmacovigilance processes, procedures and functions.
- Assist team members to liaise effectively with internal departments and external suppliers to support the timely introduction of new products to the US market. Support the launch a product in the US by being involved in all pre-commercial regulatory and pharmacovigilance activities
- Perform post-marketing safety surveillance activities. including but not limited to
- Lifecycle management of supplier Safety Data Exchange Agreements within eQMS
- Evaluate spontaneous adverse events and reports from literature
- Review and approval of safety reports (including but not limited to expedited reports, periodic ADE reports, signal trending reports)
- Interface with key pharmacovigilance service providers
- Prepare the annual PV audit schedule applying a risk based approach
- Perform PV audits of ANDA applicants and PV service providers
- Support medical communications queries in accordance with applicable Safety Data Exchange Agreements
- Maintain a good understanding of existing and emerging pharmaceutical regulations and evaluate the impact on the private label business
- Liaise effectively with internal departments and external suppliers to support the new product launch process for McKesson US Private Labels
- Operate within the Quality Management System across all regulatory related activities
- Preparation of monthly metrics and reports
- Participate in regular team and group meetings ensuring to keep the management team updated on issues and actions which impact the business
- Support cross-training opportunities and skills
- Provide day-to-day department support activities as necessary to aide completion of project deliverables
(The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties.)
Educated to degree level or higher in Chemistry, Microbiology or other scientific discipline.
Experience in a Regulatory Affairs or Quality role in a regulated pharmaceutical organization is advantageous.
Knowledge and Skills:
- Ability to work collaboratively as part of the Regulatory Affairs and wider business team
- Multi-tasking and time management skills with the flexibility to change work direction as needed
- Technical writing skills
- Strategic problem solving and decision-making ability.
- Strong communication and interpersonal skills
- Effective team building ability.
- A continuous improvement mindset
- Influencing skills with a demonstrated ability to achieve results.
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 supportphysical, 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.
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€22,500 - €37,500
How we work and live plays a big role in building a healthier world. View our wide range of health benefits, financial benefits, wellness programs, and flexible working schedules.
Ready for the next step? We’ll guide you along the journey of our hiring process.
Culture and Values
Advancing health outcomes for all — this is the foundation of how we interact with customers, business partners, and each other. Meet the team and learn more about our mission.
Diversity, Equity & Inclusion
Our culture is built around diverse perspectives because everyone’s unique story, experiences, and ideas are valued here.
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