Career Opportunity as a Safety Specialist at Thermo Fisher Scientific – Apply Now

Welcome to an exciting career opportunity at Thermo Fisher Scientific! We are thrilled to announce an opening for the position of Safety Specialist, a role that plays a pivotal part in fostering a culture of safety and well-being within our dynamic and innovative organization.

In this comprehensive guide, we’ll explore the intricacies of the Safety Specialist role, providing insights into responsibilities, qualifications, and the unique work environment at Thermo Fisher. Whether you’re an experienced safety professional looking for a new challenge or a dedicated individual passionate about contributing to workplace safety, this is your chance to make a significant impact.

Job Description:
Join Thermo Fisher Scientific’s dynamic team of colleagues in clinical research services, at the forefront of bringing cures to market. As a global contract research organization (CRO), our Clinical Research team powers the PPD® clinical research portfolio, tackling the world’s most challenging health concerns.

Position: Safety Specialist
Location: Remote, India

Essential Functions:
1. Perform day-to-day Pharmacovigilance (PV) activities within a highly regulated environment, ensuring adherence to strict timelines.
2. Conduct PV activities, including collection, monitoring, assessment, evaluation, research, and tracking of safety information.
3. Coordinate and perform data entry, coding, adverse event assessment, case review, follow-up, tracking of reports, and regulatory reporting activities.
4. Collaborate effectively with project team members, client contacts, investigators, adverse event/reporters, and third-party vendors.
5. Participate in on-call duties for specific projects to ensure 24-hour coverage for the intake of cases from investigative sites.
6. Review regulatory/pharmacovigilance publications to stay updated on current regulations, practices, procedures, and proposals.
7. Maintain medical understanding of applicable therapeutic areas and disease states.
8. Review cases entered for quality, consistency, and accuracy, including peer report reviews.
9. Prepare and maintain regulatory safety reports.
10. Assist in routine project implementation and coordination, including presentations at client/investigator meetings and the review of metrics and budget considerations.
11. Mentor less experienced staff.

Education and Experience:
1. Bachelor’s degree or equivalent with a relevant formal academic/vocational qualification.
2. Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
3. Equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, may be considered sufficient in some cases.

Knowledge, Skills, and Abilities:
1. General understanding of pathophysiology and the disease process.
2. Detailed knowledge of relevant therapeutic areas for processing Adverse Events (AEs).
3. Strong critical thinking and problem-solving skills.
4. Good oral and written communication skills, including paraphrasing.
5. Proficient in English, with the ability to translate information into the local language when required.
6. Computer literate with the ability to work within multiple databases.
7. Previous exposure to Microsoft Office packages (Outlook, Word, and Excel).
8. Understanding of the importance of and compliance with procedural documents and regulations.
9. Ability to manage and prioritize tasks, meeting strict deadlines with limited supervision.
10. Strong attention to detail.
11. Ability to maintain a positive and professional demeanor in challenging circumstances.
12. Effective team player committed to attaining shared goals.
13. Embark on a rewarding career with Thermo Fisher Scientific. Apply for the Safety Specialist position and contribute to advancing clinical research and pharmacovigilance from the comfort of your remote workspace.

Job ID: R-01222787
Job Type: Full Time
Category: Clinical Research
Remote: Fully Remote

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