Job Posting: Safety Specialist in Pharmacovigilance at Thermo Fisher Scientific
About Us
Thermo Fisher Scientific’s clinical research services team is dedicated to bringing cures to market. We provide top-tier scientific and clinical expertise to develop drugs that address the world’s most challenging health concerns. As part of our PPD® clinical research portfolio within our global contract research organization (CRO), we are at the forefront of clinical research and drug development.
| Position Name | Safety Specialist in Pharmacovigilance |
|---|---|
| Organization | Thermo Fisher Scientific |
| Qualification | B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences |
| Experience | 1 to 2 Years |
| Salary Range | ₹4.8 Lakhs to ₹6.5 Lakhs |
| Location | Work From Home |
Job Details
- Job Title: Safety Specialist III
- Location: Remote, India
- Job ID: R-01243764
- Job Type: Full-time
- Category: Clinical Research
- Remote: Fully Remote
Job Description
The Safety Specialist III oversees daily pharmacovigilance (PV) activities in a highly regulated environment. Responsibilities include collection, monitoring, assessment, evaluation, research, and tracking of safety information. This role involves collaboration with project team members, client contacts, investigators, adverse event reporters, and third-party vendors. The Safety Specialist III operates independently and may participate in on-call duties to ensure 24-hour case intake coverage from investigative sites.
Key Responsibilities
- Pharmacovigilance Activities: Conduct day-to-day PV activities including collection, monitoring, assessment, evaluation, research, and tracking of safety information.
- Collaboration: Work effectively with project team members, client contacts, investigators, adverse event reporters, and third-party vendors.
- Leadership: Lead in developing program and departmental procedural documents. Mentor junior staff.
- Audits: Prepare for and attend audits as required.
- Regulatory Updates: Stay current with global pharmacovigilance regulations and guidelines.
- Medical Understanding: Maintain understanding of relevant therapeutic areas and disease states.
- Quality Review: Ensure case quality, consistency, and accuracy, including peer review.
- Project Coordination: Coordinate routine project tasks and presentations.
- Literature Surveillance: Review literature for adverse events and safety information.
- Primary Contact: Serve as primary contact for various literature projects.
- Compliance: Ensure tasks are compliant with company policies and regulations.
- Departmental Initiatives: Participate in departmental initiatives.
- Audits and Inspections: Prepare for and attend audits and inspections as needed.
Qualifications
- Education: Bachelor’s or advanced degree in life sciences, pharmacy, nursing, or related field.
- Regulatory Knowledge: Thorough understanding of global pharmacovigilance regulations and guidelines.
- Skills: Strong analytical, problem-solving, communication, and organizational skills. Proficiency in PV databases and relevant IT applications. Ability to work effectively in a remote, team-oriented environment.
Application Process
Interested candidates should share their resumes via email to momita.sharma@thermofisher.com.
Meta Description (19 words)
Join Thermo Fisher as a Safety Specialist in Pharmacovigilance, leveraging your expertise remotely to advance clinical research and drug development.