Thermo Fisher Scientific is seeking a Senior Safety Specialist (Night Shift) to join our Pharmacovigilance (PV) team. This role involves managing day-to-day PV activities, ensuring compliance with global regulatory requirements, and collaborating with cross-functional teams to assess and monitor drug safety data.
Key Responsibilities:
- Perform pharmacovigilance activities, including case processing, monitoring, assessment, and tracking of safety data.
- Ensure timely and accurate intake of adverse event reports from clinical trials and post-marketing surveillance.
- Review and validate case reports for quality, consistency, and regulatory compliance.
- Assist in developing departmental procedures and participate in audits.
- Stay updated on pharmacovigilance regulations, guidelines, and industry best practices.
- Provide mentorship to junior team members and support project coordination.
- Work with Argus safety database for case processing (both PMS & CT cases).
Qualifications & Experience:
- Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or Clinical Science.
- Experience: 5+ years in pharmacovigilance case processing using Argus database.
- Skills Required:
- Strong understanding of pathophysiology and therapeutic areas.
- Excellent critical thinking, problem-solving, and communication skills.
- Proficiency in Microsoft Office (Word, Excel, Outlook).
- Ability to work in night shifts (IST 5:30 PM – 2:30 AM).
- Immediate joiners preferred.
Why Join Thermo Fisher Scientific?
- Global Leader:Â Thermo Fisher is a world-renowned company in life sciences and healthcare.
- Career Growth:Â Opportunities for professional development in pharmacovigilance and drug safety.
- Work-Life Balance:Â Flexible remote work options with structured shifts.
