Job Description

Safety Data Management Associate
Job Number: 21-11028
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Safety Data Management Associate for our client in Tampa, FL.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
  • Support PV operational activities, such as tracking and following up on actions and responses of experts and other stakeholders, as well as ensuring that timelines, resources and information are coordinated and documented accurately and in a timely manner.
  • Safety Management Team Support:
    • Supports Medical Safety Physicians in leading and coordinating individual cross-functional and assigned sub-teams, such as Safety Data Review Teams.
    • Creates meeting agendas and assigned sub-teams, and documents of decisions, conclusions, timelines, milestones and action items in team minutes.
    • Identifies post-meeting actions, and ensures responsibilities and timelines are assigned and met.
    • Assesses and appropriately elevates issues impacting key activities, milestones, documents to the appropriate colleagues.
    • Plans and organizes requirements and/or resources based on Book of Work (BoW) and other upcoming tasks and activities for assigned product portfolio with oversight.
    • Applies medical, life science and general scientific knowledge and expertise to create and manage plans for designated projects with oversight.
  • Signal Detection Support:
    • Schedules Safety Data Review meetings and attends as able.
    • Generate and file AWARE reports and collaborate with Safety Analytics & Reporting (SAR), as needed.
    • Signal log entry.
    • Execute literature searches, deliver output, and retrieve full-text articles, as applicable, applying critical thinking and independent research skills to ensure the information is appropriate and usable.
    • Execute Pharmacovigilance Agreement (PVA) searches.
  • Administrative Support:
    • Manage access, permissions and content related to SharePoint Online.
    • Manage study information received in PV mailbox.
    • Maintain membership lists, mail groups, and file shares.
    • Manage mailbox/meeting calendar for assigned product portfolio.
  • Other Activities:
    • Work collaboratively with Clinical Safety Program Leads to successfully execute CSP-related activities for protocols, including tracking, reporting, querying, follow up in EDC system, etc. (TAO/RAVE).
    • Participate in process improvement projects and implementation.
    • Support preparation for regulatory inspections.
    • Close safety-related health authority queries in Verity.
    • Provide backup coverage to PV Associate II role, as needed.
  • BS/RN/MS/PharmD in life sciences or equivalent relevant scientific qualifications or professional training.
  • Bachelor of Science in life sciences or equivalent relevant scientific qualifications or professional training.
  • Minimum of 2 years' professional experience in health science or relevant life sciences/medical fields, or appropriate pharmaceutical industry or academic experience.
  • Demonstrated understanding of global pharmaceutical drug development and drug lifecycles.
  • Ideal to have:
    • Demonstrated excellence in scientific technical skills with a comprehensive understanding of pharmacovigilance processes.
    • Extensive experience in the analysis and communication of data and information to key stakeholders.
    • Project or program management experience and/or qualifications
    • Experience in working with committees and diverse teams
  • Others: US military experience will be considered towards industry and professional experience requirements
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Chris Imbien

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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