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Aggregate Report Writers

1--8 years
Not Disclosed
10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Aggregate Report Writers
Experience: 1 to 8 years
Location: Hyderabad (Onsite, Work from Office)
Company: Vigilare Biopharma


About Us

Vigilare Biopharma is a leading Contract Research Organization (CRO) in the pharmaceutical and life sciences industry. We are committed to ensuring patient safety and regulatory compliance through innovation, collaboration, and expertise in global healthcare.


Job Overview

We are seeking experienced Aggregate Report Writers to join our Pharmacovigilance team. The selected candidates will be responsible for preparing high-quality safety reports in compliance with global regulatory standards.


Key Responsibilities

  • Author and review aggregate safety reports, including:
    • Periodic Safety Update Reports (PSURs)
    • Periodic Benefit-Risk Evaluation Reports (PBRERs)
    • Annual Safety Reports (ASRs)
    • Development Safety Update Reports (DSURs)
    • Risk Management Plans (RMPs)
  • Analyze and interpret safety data from various sources to create concise, accurate reports.
  • Collaborate with cross-functional teams such as pharmacovigilance, regulatory affairs, and medical writing.
  • Ensure compliance with ICH, EMA, and FDA regulatory guidelines.
  • Meet strict timelines and quality standards for report submissions.

Qualifications

  • Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or a related field.
  • Experience: 1 to 8 years of proven experience in aggregate report writing within pharmacovigilance.
  • Regulatory Knowledge: Strong understanding of global pharmacovigilance regulations and safety data analysis.
  • Communication Skills: Excellent written and verbal communication skills.
  • Attention to Detail: Ability to manage multiple projects under tight deadlines.

Why Join Vigilare Biopharma?

✅ Be part of a mission-driven organization improving global healthcare.
✅ Work in a dynamic and collaborative environment.
✅ Competitive salary and benefits package.
✅ Professional growth and development opportunities.


How to Apply

If you are passionate about global drug safety and meet the qualifications, send your resume and a brief cover letter to:

📧 hr@vigilarebp.com
📧 CC: mayank.b@vigilarebp.com