Safety Science Coordinator Ii

2+ years

Not Disclosed

Bangalore

10 Sept. 10, 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, CPC Certified, 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

About Fortrea:

Fortrea is a leading global contract research organization (CRO) with a passion for scientific excellence and a wealth of clinical development experience. We provide pharmaceutical, biotechnology, and medical device clients with a comprehensive range of clinical development, patient access, and technology solutions. Operating in over 90 countries with more than 19,000 employees, we are dedicated to transforming drug and device development, bringing innovative solutions to patients worldwide.

Job Summary:

The selected candidate will be responsible for processing adverse event reports in accordance with client and sponsor protocols. This includes managing the receipt and accurate processing of adverse event reports from clinical trials or spontaneous sources. Key tasks involve data entry, adverse event reviews, generating patient narratives, and ensuring regulatory compliance in the submission of safety reports. The role will also include supporting quality assurance efforts, assisting with training, and providing mentorship to team members.

Key Responsibilities:

Process adverse event reports as per client/sponsor guidelines.
Manage the receipt and documentation of adverse event reports from any source or clinical trial.
Enter safety data into adverse event databases and tracking systems.
Review adverse event reports for completeness, accuracy, and compliance with expedited reporting requirements.
Accurately code adverse events using MedDRA, if applicable.
Determine listings against appropriate product labeling, when applicable.
Identify and query for missing clinically significant information, consulting medical staff as necessary.
Ensure all cases requiring expedited reporting to regulatory agencies or clients are prioritized and processed within the required timelines.
Submit expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, investigators, and other parties as agreed upon.
Assist with the processing and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
Maintain and update tracking systems, project files, and documentation related to adverse event reporting.
Conduct quality reviews and peer reviews of processed reports.
Support database reconciliation activities.
Provide guidance and mentorship to Pharmacovigilance & Safety Surveillance (PSS) staff, as needed.
Assist in the preparation of client meetings and liaise with client contacts.
Ensure compliance with regulatory requirements and internal standard operating procedures (SOPs).
Assist with audit and inspection preparation, as well as quality issue management.

Qualifications:

2+ years of relevant experience in pharmacovigilance, clinical research, or a related field.
Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related discipline is preferred.
Strong understanding of adverse event reporting and safety data management.
Excellent attention to detail and ability to work within regulatory timelines.
Strong communication skills and the ability to work collaboratively within a team.

Why Fortrea?

At Fortrea, we are seeking innovative problem-solvers and creative thinkers who share our passion for transforming clinical trials and delivering life-changing therapies to patients. We offer a dynamic and supportive work environment that fosters personal growth and encourages collaboration. Join our team to make a meaningful impact on a global scale.

Equal Opportunity Employer:

Fortrea is an Equal Opportunity Employer committed to fostering diversity and inclusion. We make all employment decisions based on the needs of our business and the qualifications of candidates. We do not tolerate discrimination or harassment of any kind based on race, religion, color, national origin, gender (including pregnancy or related conditions), family or parental status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected status. We encourage all qualified individuals to apply.

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Safety Science Coordinator Ii

Job Description

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