Sr Safety Specialist (Night Shift)

Thermo Fisher Scientific; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Pharmacovigilance Specialist to manage PV activities. In this role, you will ensure compliance with regulatory standards, oversee case processing, and mentor junior staff. Candidates must have a strong understanding of pathophysiology and be proficient in database management, especially with Argus. This position involves night shifts and requires a proactive attitude in high-pressure environments.

Qualifications

• 5+ years of experience in Case Processing activities using Argus database.
• Immediate availability and willingness to work night shifts.
• Strong knowledge of relevant therapeutic areas for AE processing.

Responsibilities

• Oversee day-to-day Pharmacovigilance activities within strict timelines.
• Review cases for quality, consistency, and accuracy, including peer reports.
• Coordinate routine project activities such as Clinical Trials.

Skills

Critical Thinking

Problem Solving

Communication

Attention to Detail

Education

Life Science or Clinical Science Graduate or Post Graduate

Tools

Argus Database

Microsoft Office

Job description

Work Schedule

Third Shift (Nights)

Environmental Conditions

Office

Job Description

Summarized Purpose:

Performs and may oversee day-to-day Pharmacovigilance (PV) activities within a highly regulated environment driven by strict timelines. PV activities include collection, monitoring, assessment, evaluation, research, and tracking of safety information. Collaborates effectively with project team members, client contacts, investigators, adverse event reporters, and third-party vendors.

Essential Functions

• Performs day-to-day PV activities independently. May participate in on-call duties for specific projects to ensure 24-hour coverage for case intake from investigative sites.
• Leads in developing program and departmental procedural documents. Prepares for and attends audits. Mentors less experienced staff.
• Reviews regulatory and pharmacovigilance publications to stay updated on current regulations, practices, procedures, and proposals. Maintains medical understanding of relevant therapeutic areas and disease states.
• Reviews cases for quality, consistency, and accuracy, including peer reports.
• Coordinates routine project activities such as Clinical Trials and Data Safety Monitoring Committees, including client/investigator presentations and review of metrics and budgets.

Qualifications:

Education and Experience:

• Life Science or Clinical Science Graduate or Post Graduate
• 5+ years of experience in Case Processing activities using Argus database
• Hands-on experience with PMS & CT Cases
• Immediate availability to join
• Willing to work night shifts (IST 5:30 PM to 2:30 AM)

Knowledge, Skills, and Abilities:

• Thorough understanding of pathophysiology and disease processes
• Strong knowledge of relevant therapeutic areas for AE processing
• Excellent critical thinking and problem-solving skills with appropriate escalation
• Proficient in clinical study administration, including budgeting and forecasting
• Excellent oral and written communication skills, including paraphrasing
• Good command of English and ability to translate into local languages
• Computer literate with experience in multiple databases
• Proficient in Microsoft Office (Outlook, Word, Excel)

• Understanding of global regulatory requirements and procedural compliance
• Ability to manage multiple tasks and meet deadlines with limited supervision
• Strong attention to detail
• Positive and professional demeanor in challenging circumstances
• Effective team player