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Aggregate Report Specialist

5-8 years
Not Disclosed
10 Feb. 6, 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

Aggregate Report Specialist - Sitero

📍 Location: India
🕒 Employment Type: Full Time, Permanent

Job Description:

Sitero is seeking an Aggregate Report Specialist to contribute to the creation and quality review of documents related to pre-marketing and post-marketing safety data. These documents support product development, licensing, and post-marketing maintenance. The role includes integrated analyses of safety data and creating reports such as Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and more. The individual will work closely with safety teams, both internal and external (including Contract Research Organizations), ensuring all reports adhere to regulatory standards and are delivered in a timely manner.

Essential Duties & Responsibilities:

  • Analyze and Interpret Safety Data: Review non-clinical, clinical, and other relevant sources for safety analysis.
  • Authoring Aggregate Reports: Create reports like PSURs, PBRERs, PADERs, DSUR, and responses to regulatory inquiries.
  • Conduct Literature Searches: Identify and present relevant articles for reports.
  • Manage Process Trackers: Track and reconcile data and reporting processes.
  • Mentorship & Training: Guide and train colleagues on aggregate report-related processes.
  • Support Regulatory Inquiries: Handle requests from regulatory agencies and risk committees.
  • Collaborate Across Teams: Work with clients, regulatory affairs, and pharmacovigilance teams to ensure compliance and timely submission.

Education & Experience Required:

  • Minimum 5 years of experience in authoring and 3 years of experience in quality review of aggregate reports.
  • Degree in Life Science, Pharma, or an equivalent field.

Preferred Skills:

  • 5-8 years of experience in authoring with 3-5 years in quality review of aggregate reports.
  • Proficiency in Microsoft Office (Outlook, Word, Excel).
  • Excellent verbal, written, and interpersonal communication skills.
  • Strong organization and prioritization skills.
  • Ability to handle fluctuating business priorities.
  • Mentorship and the ability to influence cross-functional teams.

Compensation & Benefits:

Sitero offers a competitive salary, variable pay, paid time off, and comprehensive healthcare and retirement benefits.

Commitments:

  • Standard hours: 40 hours/week, Monday – Friday with a 1-hour lunch break.
  • Willingness to work in shifts as needed.
  • Occasional extended hours to meet client requirements.

Equal Opportunity Employer:
Sitero is an equal opportunity employer and welcomes all qualified applicants, regardless of race, gender, religion, or any other protected factor.

🔗 Apply Now: Sitero Careers