Job Title: Safety Specialist III – Pharmacovigilance
Company: Thermo Fisher Scientific
Location: Work From Home
Experience Level: 1 Year
Salary: Rs. 32,000 per month
About Thermo Fisher Scientific:
At Thermo Fisher Scientific, we are dedicated to bringing cures to market and addressing the world’s most challenging health concerns. As a leading global contract research organization (CRO), we deliver high-caliber scientific and clinical expertise to drug development.
Position Overview:
As a Safety Specialist III in Pharmacovigilance, you will play a crucial role in performing Pharmacovigilance (PV) activities within a highly regulated environment. This position offers a challenging and rewarding opportunity to contribute to clinical research from the comfort of your own home.
Responsibilities:
- Collect, monitor, assess, evaluate, research, and track safety information.
- Collaborate effectively with project team members, client contacts, investigators, adverse event/reporters, and third-party vendors.
- Operate independently to perform day-to-day PV activities and participate in on-call duties for specific projects to ensure 24-hour coverage for intake of cases from investigative sites.
- Provide assistance in the development of program and departmental procedural documents and participate in audits.
- Mentor less experienced staff and stay updated on current regulations, practices, procedures, and proposals.
- Maintain medical understanding of applicable therapeutic areas and disease states.
- Review cases entered for quality, consistency, and accuracy, including peer reports.
- Conduct assessments and peer reviews of literature abstracts/articles for adverse events and special situation events.
- Serve as the primary point of contact for low, medium, and high complexity literature projects.
- Ensure assigned literature surveillance tasks are conducted in accordance with company policies, procedures, contractual agreements, and applicable regulations.
- Participate in departmental initiatives and prepare for and attend audits, inspections, and bid defenses.
Qualifications:
- Bachelor’s degree in a relevant field.
- Experience in Pharmacovigilance activities within a highly regulated environment.
- Strong interpersonal and communication skills.
- Ability to work independently and in a lead capacity.
- Medical understanding of applicable therapeutic areas and disease states.
- Familiarity with regulatory/pharmacovigilance publications and information sources.
- Experience in reviewing cases and literature abstracts/articles for adverse events.
- Proficiency in conducting literature surveillance tasks.
- Willingness to participate in audits, inspections, and bid defenses.
Apply Now:
If you are passionate about Pharmacovigilance and are looking for a challenging and rewarding opportunity to contribute to clinical research, apply now for the position of Safety Specialist III at Thermo Fisher Scientific.