Safety Specialist – Thermo Fisher Scientific (Remote)
About Company:
Thermo Fisher Scientific’s Clinical Research team, who powers our PPD® clinical research portfolio, is at the forefront of getting cures to market. We bring scientific and clinical expertise to drug development, addressing the world’s most challenging health concerns.
Job Details:
Position | Safety Specialist |
---|---|
Organization | Thermo Fisher Scientific |
Location | Remote |
Salary | ₹35,000 – ₹45,000/month |
Qualifications | B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences |
Experience | 2 years in Pharmacovigilance |
Position Name: Safety Specialist
Organization: Thermo Fisher Scientific
Location: Remote
Salary: ₹35,000 – ₹45,000/month
Qualifications:
- B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
- 2 years of experience in Pharmacovigilance
Responsibilities:
- Perform day-to-day Pharmacovigilance (PV) activities within a highly regulated environment.
- PV activities include collection, monitoring, assessment, evaluation, research, and tracking of safety information.
- Coordinate and perform PV activities such as data entry, coding, assessment of adverse events, case review, follow-up, and tracking of reports.
- Collaborate with project team members, client contacts, investigators, adverse event reporters, and third-party vendors.
- Assist in the preparation of departmental and project-specific procedures and processes.
- Prepare for and attend audits, kick-off, and investigator meetings.
Essential Functions:
- Participate in on-call duties for specific projects to ensure 24-hour coverage for intake of cases from investigative sites.
- Review regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, procedures, and proposals.
- Maintain medical understanding of applicable therapeutic areas and disease states.
- Review cases for quality, consistency, and accuracy, including peer reports.
- Prepare and maintain regulatory safety reports.
- Assist with routine project implementation and coordination, including presentations at client/investigator meetings, and review of metrics and budget considerations.
- Mentor less experienced staff.
How to Apply:
If you are interested in this opportunity, please share your updated resume.