Safety Analytics Scientist True Title: Risk Management Lead Job Summary
- The Global Drug Safety Risk (GDS) Management Lead is the drug safety expert for assigned products; maintains current knowledge of assigned product portfolio and safety profiles for products.
- He/she is responsible for safety risk assessment, management, minimization and communication for assigned development and marketed products.
- He/she is also provides input into and review of aggregate reports and safety documents, including labeling changes.
Education & Qualifications
- Responsible for the implementation of benefit-risk management for company products. Development of REMS, DRMP's & RMP's, regulatory responses for risk management topics and other product position statements as assigned for submission to regulatory agencies.
- Actively participates in Benefit- Risk Committees and other safety committees as needed. Effectively manages the Benefit/Risk process.
- Prepares and assists in the management of Risk Management project timelines. Ensure all risk management documents are prepared according to regulatory requirements, facilitate review and sign-off. Ensure all regulatory commitments in RMP's are followed & tracked.
- Represent Risk Management on cross functional teams and Interface with other company functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed.
- Communicates effectively on product risks to Risk Management Team Lead.
- Provide advice and liaises with the Global Safety Leads that improve the consistency and accuracy of Benefit Risk assessment.
- Critically review & provide medical/safety input of PBRER, RMP, DSUR, Clinical Expert statement, Regulatory responses, IB, NDA Submissions, MAA Submission & ad hoc reports. Ensures that the safety risks with Shire projects/products are identified promptly
- Represent GDS- Risk Management for internal and external Risk Management forums as safety and risk management experts, including regulatory agency meetings such as EMA, FDA as needed
- Contribute to on-going process enhancement for safety surveillance such as developing standard procedures and templates
- Participate in other activities, teams and committees as assigned
- MD, PhD, Pharm D, or Master's degree in a science or healthcare related discipline with specialty training in functional area and at least 3 plus years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products
- At least 2 years of experience writing and preparing risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies or commensurate experience.
- Previous experience in bioscience preferred
- Ability to read and analyze scientific and medical literature
- Ability to work with interdisciplinary, highly matrixed team
- Knowledge and active use of Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat
- Analytical and problem solving skills
- Oral and written communication and interpersonal skills
- Planning and Organizing
- Ability to manage multiple projects simultaneously while remaining responsive to strict deadlines
- Ability to establish and maintain professional communication both internally and externally with all stakeholders
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.