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.
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