Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description

Join Us as Associate Safety Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in patient safety. As Associate Safety Specialist, you'll perform day-to-day Pharmacovigilance (PV) activities within a highly regulated workplace driven by strict timelines. Your responsibilities will include, but are not limited to, the collection, monitoring, assessment, evaluation, research, and tracking of safety information. You will perform activities such as adverse event data entry, coding, assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. You will effectively collaborate with various parties such as project team members, client contacts, investigators,



adverse event reporters, and third-party vendors.

What You’ll Do:
• 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.
Education and Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

In some cases an equivalency, consisting

📌 FSP – Associate Safety Specialist (India)
🏢 Thermo Fisher Scientific
📍 India