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Job Title: Safety Specialist III
Company: Thermo Fisher Scientific
Location: Remote, India
Job Type: Full-time
Category: Clinical Research
Remote: Fully Remote
Job ID: R-01243764
About Us:
Our team in clinical research services 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.
Job Description:
The Safety Specialist III is responsible for performing and overseeing day-to-day pharmacovigilance (PV) activities in a highly regulated environment with strict timelines. This role includes the collection, monitoring, assessment, evaluation, research, and tracking of safety information. The Safety Specialist III collaborates with various stakeholders such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors. This role operates independently and may participate in on-call duties for specific projects to ensure 24-hour coverage for the intake of cases from investigative sites.
Key Responsibilities:
Pharmacovigilance Activities:
- Collect, monitor, assess, evaluate, research, and track safety information.
Collaboration:
- Collaborate with project team members, client contacts, investigators, adverse event reporters, and third-party vendors.
Leadership:
- Lead program and departmental procedural document development.
- Mentor less experienced staff.
Audits:
- Prepare for and attend audits as required.
Regulatory Updates:
- Stay updated on current regulations, practices, procedures, and proposals by reviewing regulatory/pharmacovigilance publications and information sources.
Medical Understanding:
- Maintain knowledge of applicable therapeutic areas and disease states.
Quality Review:
- Review cases for quality, consistency, and accuracy, including peer report review.
Project Coordination:
- Coordinate routine project implementation, client/investigator meetings, and review of metrics and budget considerations.
Literature Surveillance:
- Assess and peer review literature abstracts/articles for adverse events, special situation events, signal-relevant and aggregate safety report-relevant safety information, and analysis of similar events for both developmental and market-authorized products.
Primary Contact:
- Serve as the primary contact for literature projects of varying complexity.
Compliance:
- Ensure tasks comply with company policies, procedures, contractual agreements, and applicable regulations.
Departmental Initiatives:
- Participate in departmental initiatives.
Audits and Inspections:
- Prepare for and attend audits, inspections, and bid defenses as needed.
Qualifications:
| Requirement | Preferred |
|---|---|
| Education: | Relevant Bachelor’s or advanced degree in life sciences, pharmacy, nursing, or a related field. |
| Regulatory Knowledge: | Thorough understanding of global pharmacovigilance regulations and guidelines. |
| Skills: | – Strong analytical and problem-solving skills. |
Meta Description:
Join Thermo Fisher Scientific as a remote Safety Specialist III in India to oversee pharmacovigilance activities. Apply now!