Safety Specialist

Lensa; United States; On-site; USD 65,000 - 75,000; Full time

Job summary

A career site is promoting a Pharmacovigilance role involving collection and evaluating of safety information within a regulated environment. The ideal candidate should have a Bachelor's degree and 4+ years of experience in PV case processing, with a focus on regulatory compliance and data management tasks. This full-time position is ideal for professionals who are detailed-oriented and possess strong problem-solving skills.

Qualifications

• Min 4+ years of experience in PV case processing.
• Should have worked in Clinical Trial and PMS cases.
• Good command of English.

Responsibilities

• Performs day-to-day Pharmacovigilance activities.
• Coordinates and performs PV activities.
• Assists in preparation of regulatory safety reports.

Skills

Critical thinking

Problem solving

Attention to detail

Communication

Education

Bachelor's degree

Tools

Argus Database

Microsoft Office

Job description

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Lensa is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. Lensa does not hire directly for these jobs, but promotes jobs on LinkedIn on behalf of its direct clients, recruitment ad agencies, and marketing partners. Lensa partners with DirectEmployers to promote this job for Thermo Fisher Scientific.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summarized Purpose:

Performs 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. Coordinates and performs Pharmacovigilance activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors. May assist in the preparation of departmental and project-specificprocedures and processes, prepare for and attend audits, kick-off and investigator meetings.

Essential Functions

• Performs 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.
• 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.
• Prepares and maintains regulatory safety reports.
• Assists with 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. Mentors less experienced staff
  
  

Education And Experience

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Knowledge, Skills And Abilities

• Min 4+ Years of expereince in PV case processing
• Should have worked in Clinical Trial and PMS cases
• Should have working expereince in Argus Database
• General understanding of pathophysiology and the disease process
• Detailed knowledge of relevant therapeutic areas as required for processing AEs
• Strong critical thinking and problem solving skills
• Good oral and written communication skills including paraphrasing skills
• Good command of English and ability to translate information into local language where required
• Computer literate with the ability to work within multiple databases
• Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)
• Understanding the importance of and compliance with procedural documents and regulations
• Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
• Strong attention to detail
• Ability to maintain a positive and professional demeanor in challenging circumstances
• Ability to work effectively within a team to attain a shared goal
  
  

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

If you have questions about this posting, please contact [e-mail]

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  IT Services and IT Consulting

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