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Safety Science Specialist

2+ years
Not Disclosed
10 Nov. 15, 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

Position: Pharmacovigilance Specialist
Location: Bangalore
Company: Fortrea

About Fortrea:

Fortrea, a global leader in contract research with over 19,000 staff in 90+ countries, partners with the pharmaceutical, biotechnology, and medical device industries to advance clinical development and improve patient access across more than 20 therapeutic areas. Our commitment to scientific rigor and innovation supports the swift development of life-changing therapies worldwide.

Job Overview:

Fortrea seeks an experienced Pharmacovigilance (PV) Specialist to manage adverse event reporting and ensure compliance with regulatory standards. This role supports clinical trials and post-market surveillance to safeguard patient safety, manage data accuracy, and drive seamless communication with stakeholders.

Key Responsibilities:

  • Adverse Event Management: Oversee receipt and processing of adverse event reports from various sources; review for completeness and prepare patient narratives, code adverse events using MedDRA, and ensure cases meet expedited reporting requirements.
  • Regulatory Submissions: Manage SAE report submissions to regulatory authorities, clients, and ethics committees within specified timelines.
  • Quality and Compliance: Perform quality and peer reviews, ensure SOP compliance, and support root cause analysis for quality issues.
  • Documentation and Reporting: Maintain adverse event tracking systems, prepare ESRs and PSRs, and assist with database reconciliation.
  • Safety Communication: Liaise with project personnel, participate in safety committees as needed, and assist in client meetings.
  • Audit and Inspection Support: Prepare for audits and inspections and ensure appropriate document archiving.

Qualifications:

  • Experience: Minimum of 3 years in pharmacovigilance, with expertise in clinical trial case processing.
  • Skills: Strong understanding of SOPs, safety management protocols, and regulatory reporting.
  • Location: Bangalore

Why Fortrea?

Joining Fortrea means being part of a global team passionate about overcoming barriers in clinical trials. We support professional growth in a collaborative environment where you can make a meaningful global impact.

Equal Opportunity Employer:

Fortrea values diversity and inclusivity. We make employment decisions based on business needs and qualifications and do not discriminate based on any legally protected characteristic. All are encouraged to apply.

Learn More and Apply: www.fortrea.com