The Global PMS Lead is responsible for the oversight of Post-marketing surveillance (PMS) studies/activities to ensure compliance with Post-marketing regulations, commitments and milestones in Risk Management Plans
- Accountable for the global tracking of ongoing and planned PMS studies and study activities.
- Accountable for monitoring study progress, updating aggregate reports and providing updates to the Safety Review Team as needed.
- Collaborates closely with the Local Country offices, including Medical affairs, Drug Safety, and Regulatory Affairs in support of PMS studies, Pharmacovigilance programs and other activities undertaken as part of RMP commitments.
- Coordinates and contributes to the development of PMS study protocols, study reports and other related documents/commitments.
- Develops protocols, study timelines and project management for other RMP commitments, such as EU- educational materials effectiveness surveys, US- REMS, etc. as assigned for submission to regulatory agencies.
- Facilitates global review and approval of protocol synopses, protocol/protocol amendments, and study reports.
- Monitors timelines and milestones to ensure compliance with regulatory commitments.
- Facilitates and provides study support and guidance as needed.
- Maintains awareness of worldwide Regulatory Guidance on PMS studies, Pharmacovigilance and Risk Management.
- Liaises effectively with local country offices and local affiliates in the understanding of local and country regulations which affects Post-marketing commitments
- Represents PMS team on cross functional teams and interfaces with other functional groups such as Regulatory Affairs, Clinical Development, Clinical Operations, Medical Affairs, Compliance, as needed.
- Communicates study updates/results to the Global Safety Lead and the Qualified Person for Pharmacovigilance (QPPV) as needed.
- Critically reviews and provides input into MAA Submission/Product license renewals, ad hoc submission responses, PBRERs, RMPs and other regulatory responses related to PMS activities.
- Ensures Post-marketing commitments in RMPs are tracked.
- Ensures that study timeline risks with PMS projects are identified promptly, and mitigation plans are put into place.
- Contributes to on-going process enhancement for PMS studies and other post-marketing activities
- Master s degree in a science or healthcare related discipline
- Formal training or equivalent experience in epidemiology, public health
- Experience in Pharmacovigilance/Risk Management
- Experience in a medical field is preferred.
- Generally, has 3+ years of experience in conducting PMS studies or developing/implementing Risk Management Programs for pharmaceutical products
- Ability to improvise and demonstrate creativity in solving problems and achieving objectives
- Proficiency with electronic search engines of the medical literature (MEDLINE, EMBASE, etc.)
- Ability to read and analyze scientific and medical literature
- Ability to work with interdisciplinary, highly matrixed team
- Knowledge of global regulations and guidance on risk management
- Requires strong attention to detail in composing and proof-reading materials, establishing priorities, scheduling and meeting deadlines
- Excellent written, oral communication and presentation skills
- Experience in Project Management
- Must be able to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands
- Ability to work independently, take initiative and complete tasks to deadlines
- Working knowledge of MedDRA terminology and practices is a must
- Good working knowledge of MS Word, Excel, PowerPoint and Outlook
- Participates in other activities, teams and committees as assigned
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Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.