Pharmacovigilance Intern

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

Mallinckrodt is a company united around a central pursuit-improving outcomes for underserved patients with severe and critical conditions. As a purpose-driven organization with a broad network and relentless determination, we create products, delivery systems and solutions for patients whose needs have not been met.

Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty and generic pharmaceutical products and therapies. With locations in the US, Canada, Europe and Asia, culture is one of the most important aspects of our organization. Who we are at the core of our company - how we think, feel and work together means everything.We are anchored in our values of Patient Centricity, Innovation, Collaboration and Integrity.

The Company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. We are focused on listening for needs and delivering solutions. We provide medicines to address unmet patient needs, stemming from 155 years of using our unique strengths, experience and expertise to help improve people's lives.

We know that we contribute to something that matters because we make quality products that impact patient lives. We have built an inclusive community and recognize the importance of every employee as a whole person - inside and outside of work. Our dynamic work environment provides unique experiences for employees to grow and develop.

We are moving forward - come with us.

Mallinckrodt is offering an 11-week internship program, which provides an immersive experience in the world of pharmaceuticals. As an MNK Intern, you will have the opportunity to contribute to meaningful and impactful work that compliments the degree you are pursuing. Here, you will be able to apply what you've learned in the classroom to a corporate environment. In addition, our internship program is designed to include networking opportunities across the company, professional development workshops, and community service.

Mallinckrodt is united around our mission-Listening for needs. Delivering solutions. Join us to get a sense of what it's like to work at Mallinckrodt and gain the real-world experience you are seeking.

• The Pharmacovigilance (PV) Summer Intern will assist in the functions of the SpecGx LLC ("The Company") PV department located in Webster Groves, MO, and the operations of all clinical and post-marketing adverse event filings to the US Food and Drug Administration received globally. The PV Summer Intern will also learn about the implementation, and compliance of Safety Data Exchange Agreements (SDEAs) with Safety Partners. In this position, the PV Summer Intern will have exposure to relevant inter-departmental teams representing PV as determined necessary by the Manager, Post-Market Surveillance.

Essential Functions

• Assist the SpecGx LLC PV Department operations including the processing and reporting of PV information to regulatory bodies. This includes entry of safety data, processing, review of adverse events for completeness, accuracy and consistency of assessments and coding.
• Partner with the Vendor/CRO for adherence to global regulations and guidance.
• Assist in the compilation and review of data for aggregate safety reports.
• Monitor operational metrics for the PV Department for overall performance.
• Review PV Standard Operating Procedures, Work Instructions and Guidance.
• Liaise with Global Pharmacovigilance personnel.
• Support strategy and project plan for the integration of newly marketed pharmaceutical products into SpecGx systems.
• Support organizational initiatives to drive global operational excellence in PV.

Education / Experience / Skills:

• Education Required:
  • Allied Healthcare Student working towards a PA, BSN, PharmD, DVM, or MD degree.
• Experience:
  • Completion of the second year of a professional curriculum in an accredited US college or university.
• Preferred Skills/Qualifications:
  • Strong oral and written communication skills
  • Comfortable and capable of utilizing software programs such as Excel, Word, and PowerPoint
  • Sound organizational skills with the ability to prioritize tasks

• The PV Summer Intern will report directly into the Manager, Post-Market Surveillance
• Additionally, the PV Summer Intern will interact with a variety of divisional and corporate departments. These include, but are not limited to Regulatory Affairs, Product Monitoring and Medical Information.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.