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Senior Associate Pv (Aggregate)

3-4 years
Not Disclosed
10 April 17, 2025
Job Description
Job Type: Full Time Education: B.Pharmacy / M.Pharmacy / Pharm.D 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

Senior Associate – Pharmacovigilance (Aggregate Reports)
Location: Hyderabad, India
Experience Required: 3–4 Years
Qualification: B.Pharmacy / M.Pharmacy / Pharm.D


Position Overview

We are seeking an experienced Senior Associate – Pharmacovigilance specializing in Aggregate Reports to join our team in Hyderabad. The ideal candidate will have a strong background in pharmacovigilance, specifically in ICSR processing (from literature sources) and the preparation of aggregate safety reports.


Required Qualifications

  • Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm) or Doctor of Pharmacy (Pharm.D).


Preferred Skills & Competencies

  • 3–4 years of hands-on experience in pharmacovigilance with a focus on ICSR and aggregate reports.

  • Strong understanding of:

    • Medical terminology

    • Clinical pharmacology

    • Patient treatment pathways

    • Diagnostic investigations and pathology

  • In-depth knowledge of pharmacovigilance principles and international regulatory safety requirements.

  • Proficient in English – excellent written, verbal, and presentation skills.

  • Strong attention to detail.

  • Excellent time management, planning, and organizational skills.

  • Ability to work independently and collaboratively in a global team environment.


Key Responsibilities

  • Prepare aggregate safety reports (PSURs, PBRERs, PADERs) including planning, drafting, and finalization.

  • Contribute to the preparation of RMPs and signal management reports.

  • Maintain and update aggregate report calendars in compliance with regulatory authorities.

  • Generate and review line listings and summary tabulations.

  • Conduct literature searches and reviews for report inclusion.

  • Participate in internal/external audits and inspections.

  • Manage daily tasks to meet project timelines and deliverables.

  • Collaborate with cross-functional teams and stakeholders.

  • Perform reconciliation activities with clients.

  • Support and manage PV meetings, client interactions, and documentation (e.g., drafting Minutes of Meeting).

  • Monitor health authority websites for new updates and guidance.

  • Initiate CAPAs when process non-conformance is identified.

  • Archive finalized documents per SOPs and regulatory compliance.

  • Train new/junior team members on SOPs, regulatory updates, and pharmacovigilance best practices.

  • Perform additional PV-related duties as assigned by management.