Safety Data Management Associate
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 are up to the challenge, then take a chance at this rewarding opportunity!
Position Summary: Pharmacovigilance (PV) Associate
Detailed Position Responsibilities
- The Pharmacovigilance Associate is a member of the Epidemiology, Safety Science and Analytics group which coordinates, tracks and analyzes medical safety assessments, surveillance and data in clinical development activities.
- The incumbent has a key role in tracking and following up on actions and responses of experts and other stakeholders, ensuring that timelines, resources and information are coordinated and documented accurately and in a timely manner.
Must have requirements:
- Supports Medical Safety Assessment Physicians (MSAP) in leading and coordinating individual cross-functional Medical Surveillance Teams (MSTs) and assigned sub-teams, such as Safety Data Review (SDR) Teams.
- Creates meeting agendas for MST 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 MST activities, milestones, documents to the appropriate Global Pharmacovigilance & Epidemiology (GPV&E) colleagues.
- Leads, plans, organizes, and forecasts requirements and/or resources based on Book of Work and other upcoming tasks and activities for assigned product portfolio.
- Executes searches of the corporate safety database, J-review database and the worldwide literature, applying critical thinking and independent research skills to ensure the information is appropriate and usable.
- Applies medical, life science and general scientific knowledge and expertise to create and manage plans and budgets for designated projects.
Ideal Candidates Would Also Have:
- 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.
- 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
Interested in applying?
Contact Joy Retanan at (646) 695-2949 or at http://www.linkedin.com/pub/joy-retanan/85/4ba/333 or send your resume to Joy.Retanan@eclaro.com now.
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.