Safety Science Coordinator I

1-6 years

Not Disclosed

Mumbai Pune

15 June 6, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company: Fortrea

Industry: Global Contract Research Organization (CRO)

Website: www.fortrea.com

About Fortrea:

Fortrea is a leading global contract research organization (CRO) known for its scientific rigor and decades of clinical development experience. The company provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff operating in more than 90 countries, Fortrea is dedicated to transforming drug and device development for partners and patients worldwide.

Role and Responsibilities:

Position: Clinical Safety and/or PSS Operations Specialist

Key Responsibilities:

Assist with overall Clinical Safety and/or PSS operations associated with products, including the entire adverse events process.
Manage and process expeditable adverse events to required standards and submit them to clients and/or regulatory agencies within agreed timelines.
Provide services to clients as either a support function to client project groups or as a stand-alone business.
Ensure the provision of appropriate quality of service to all clients, both internal and external, in a safe and cost-effective manner.
Comply with legal requirements, including the Health & Safety at Work Act 1974, the COSHH regulations 1989, and the EC Directives 1992/3 as documented in the Company’s Health & Safety Manual.

Requirements:

Strong understanding of clinical safety and adverse events processes.
Experience with safety data collection from clinical trials and/or post-marketing settings.
Ability to manage and process adverse events to high standards.
Compliance with regulatory requirements and company policies.

Company Values:

Commitment to Innovation: Fortrea is actively seeking motivated problem-solvers and creative thinkers who share a passion for overcoming barriers in clinical trials. The company's commitment is to revolutionize the development process to ensure the swift delivery of life-changing ideas and therapies to patients in need.

Collaborative Work Environment: Join Fortrea’s exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

Equal Opportunity Employment:

Fortrea is proud to be an Equal Opportunity Employer. As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without discrimination based on race, religion, color, national origin, gender, family or parental status, marital status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

Privacy Statement: For more information about how Fortrea collects and stores your personal data, please see our Privacy Statement on the company website.

Join Fortrea: Join Fortrea to embrace a role where you can make a significant impact in clinical development, ensuring the swift delivery of life-changing therapies to patients.

Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide.

As a member of Fortrea’s Global Talent Network, you'll:

Be the first to know about exciting opportunities that align with your career interests.
Stay informed about the latest trends and developments in the clinical research industry.
Be invited to exclusive events and meet with Fortrea leaders to learn more about our company and culture.

To stay up-to-date on the latest news, follow us on LinkedIn, Facebook and Twitter.

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Safety Science Coordinator I

Job Description

About Fortrea:

Role and Responsibilities:

Company Values:

Equal Opportunity Employment:

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