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Manager Clinical Safety Scientist I

Basking Ridge, NJ 07920

Posted: 05/22/2023 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 566756-1 Is job remote?: No Country: United States

Job Description

Duties:
Summary
  • This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit risk profile throughout product lifecycle Independently leads activities without supervision for assigned clinical studies
  • Lead activities under the direction of Clinical Safety Scientist Product Lead
  • Develop expertise in one or more focus areas (SME)
  • Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation

Responsibilities
  • Risk Management (Signal identification, evaluation, mitigation):
    • Supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit risk profile throughout product lifecycle
    • Collaborates with Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data of any source to identify potential safety signals, tracks safety signals in the global electronic signal tracking tool and performs safety analysis/evaluation. May contribute to safety action recommendations, and communication and risk minimization plans. Presents assessment to the appropriate forums, including Safety Management Team (SMT) or other cross-functional teams
    • Collaborates with Clinical Safety Scientist Lead and PSL to develop materials (presentation, safety analyses / evaluation, etc.) for SMT/Product-level safety meetings
    • Collaborates with Clinical Safety Scientist Product Lead and PSL to develop minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs)
    • Collaborates with Clinical Safety Scientist Product Lead and PSL to develop the Safety Management Plan for assigned product
  • Safety Communication:
    • Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documents
    • Collaborates with Clinical Safety Scientist Lead and PSL to author safety sections of Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)
    • Contributes to regulatory authority requests or communication for assigned clinical studies
  • CTD submissions/Others
    • May support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist Lead, Clinical Safety Physician(s), PSL, and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of CTD
    • Develop expertise in one or more focus areas
    • Supports Data Monitoring Committees (DMCs) and due diligence activities for assigned product(s), as needed
    • Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation
  • Project Management:
    • Coordinates SMT/Product-level safety meetings, maintains roster, calendar, and minutes, and communicate materials, in support of the Clinical Safety Scientist Product Lead and PSL
    • May serve as a project manager for other activities involving assigned product(s) or clinical studies, as needed
Skills:
  • Possesses scientific or therapeutic area, and drug development knowledge preferred
Education:
 
  • 0-1 year of experience with an advanced degree required
  • 2-3 years of experience with a Bachelor’s degree required

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Basking Ridge, NJ

Discover exciting job opportunities in the vibrant area surrounding Basking Ridge, New Jersey! Known for its picturesque landscapes, rich history, and thriving business community, Basking Ridge offers an unparalleled quality of life for professionals seeking growth and success. With easy access to NYC and iconic landmarks like the historic Jacobus Vanderveer House and the stunning Scherman Hoffman Wildlife Sanctuary, this charming region provides a perfect blend of career prospects and leisure pursuits. Indulge in locally sourced cuisine, catch a show at the elegant Ridge Performing Arts Center, or explore the natural beauty of Lord Stirling Park. Embrace the unique culture and endless possibilities that Basking Ridge has to offer as you explore our latest job listings and embark on a fulfilling career journey in this enchanting area.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.