Thermo Fisher Scientific is hiring Safety Specialist III – B. Pharma/ M. Pharma/ Pharma D/ B. Sc/ M. Sc can apply

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Are you looking for a rewarding remote career in safety management? Thermo Fisher Scientific, a global leader in serving science, is hiring a Safety Specialist III for a work-from-home position. Join our team and help us make the world healthier, cleaner, and safer by ensuring the highest standards of safety in our operations. Apply today to become a part of a company that values innovation, integrity, and a commitment to excellence.
Position Safety Specialist III
Department Clinical Research
Education B. Pharma/ M. Pharma/ B. Sc/ M. Sc/ Pharma D
Salary Competitive

Job Description

  • Performs and may oversee day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information.
  • Effectively collaborates with various parties such as: project team members, client contacts, investigators and adverse event/ reporters, and third party vendors.
    Works independently to perform day-to-day PV activities. May participate in on call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
  • Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits.
  • Mentors less experienced staff.
  • Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
  • Maintains medical understanding of applicable therapeutic area and disease states.
  • Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
  • Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.
  • Conducts assessment and peer review of literature abstracts/articles for adverse events, special situation events, signal-relevant and aggregate safety report-relevant safety information, and analysis of similar events (AOSE) for both developmental and market-authorized products.
  • Serves as the primary point of contact for low, medium and high complexity literature projects (e.g. high complexity projects with more than 5 products, projects involving review for ICSRs, signal-relevant, aggregate safety report-relevant safety information and/or AOSE, and projects with high volume of citations).
  • Ensures that assigned literature surveillance tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.
  • Participates in departmental initiatives.
  • May prepare for and attend audits, inspections and bid defenses.
Job Location Remote, India
Job Type Full Time
Apply Online Click Here


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