Instagram
youtube
Facebook

Lead Safety Science Specialist

5+ years
Not Disclosed
10 Aug. 23, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

Fortrea is a global leader in Contract Research Organizations (CROs), driven by scientific excellence and extensive clinical development experience. We offer pharmaceutical, biotechnology, and medical device clients a diverse range of solutions in clinical development, patient access, and technology across over 20 therapeutic areas. With a team of more than 19,000 professionals operating in over 90 countries, Fortrea is dedicated to advancing drug and device development for partners and patients worldwide.

Job Description:

The following statements outline the general responsibilities and expectations for the role, but are not exhaustive of all duties, skills, and responsibilities:

  • Adverse Event Management: Oversee the receipt and processing of adverse event reports from all sources, including spontaneous reports and those solicited from clinical trials. This includes safety database entry, AE review, writing patient narratives with coding, follow-up on missing information, and listed-ness assessment against applicable labels for marketed products.
  • Safety Report Submission: Ensure timely submission of Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, third-party vendors, partners, and Fortrea project personnel, as required by study timelines.
  • Prioritization and Reporting: Prioritize and process cases requiring expedited reporting to global Regulatory Agencies or other recipients within regulatory and study-specific timelines. Prepare and submit pharmacovigilance reports, including Individual Case Summary Reports (ICSRs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Reports (DSURs), Periodic Reports (PRs), and aggregate reports.
  • Quality Control and Reconciliation: Conduct peer/independent QC of safety reports as needed. Work with Data Management or clients to reconcile safety databases. Maintain thorough knowledge of Fortrea’s and client-specific database conventions.
  • Procedural Compliance: Understand and adhere to Fortrea’s PSS Standard Operating Procedures (SOPs), Work Instructions (WIs), and guidance documents related to safety management and pharmacovigilance.
  • Signal Detection and Reporting: Assist with signal detection, trend analysis, and pattern recognition. Monitor workflow for assigned studies/programs to ensure adherence to timelines. Contribute to the development of departmental Work Instructions (WIs) and SOPs.
  • Training and Support: Train and support less experienced safety staff in case-handling, adverse event reporting, and other relevant tasks. Prepare Safety Management Plans (SMPs) and Reconciliation Plans under supervision.
  • Client and Project Interaction: Participate in project team and client meetings. Liaise with clients as necessary. Assist with proactive quality issue resolution, audit preparations, and the review of cumulative safety data.
  • Additional Duties: Assist with endpoint committees coordination, safety committee set-ups, and any other tasks assigned by management.

Experience and Qualifications:

  • Experience Required: Minimum of 5 years in a relevant field.
  • Educational Background: Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related area is preferred.

Location: Bangalore

Why Join Fortrea?

Fortrea is looking for driven, innovative thinkers who are passionate about overcoming challenges in clinical trials. We are committed to revolutionizing the development process, ensuring that life-changing therapies reach patients swiftly. Join us to experience a collaborative work environment where personal growth is fostered, enabling you to make a significant global impact.

Equal Opportunity Employer:

Fortrea is an Equal Opportunity Employer. We are dedicated to creating a diverse and inclusive workforce and do not tolerate discrimination or harassment of any kind. Employment decisions are made based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family status, sexual orientation, gender identity, age, veteran status, disability, or any other legally protected characteristic. We encourage all qualified individuals to apply.

For details on how we manage your personal data, please refer to our Privacy Statement. Learn more about us at www.fortrea.com.