Job Title:
Aggregate Report Analyst – Manager
Location:
Chennai, India
Employment Type:
Full-time
Job ID:
4938857
Posted Date:
12 Days Ago
Company Overview:
Pfizer is dedicated to breakthroughs that change patients’ lives, innovating daily to deliver life-changing medicines globally.
Values:
Integrity, collaboration, and scientific excellence
Clear focus on achieving patient-centered outcomes
Position Purpose:
The PSSR Aggregate Report Analyst – Manager is responsible for creating and managing documents related to post-marketing safety data to support:
Product development
Regulatory license applications
Post-marketing maintenance
Documents may include:
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Addenda to Clinical Overviews (ACOs)
New Drug Application Periodic Adverse Drug Experience Reports
Safety Update Reports (SURs)
Canadian Annual Reports
Risk Management Plans (RMPs)
Responses to regulatory queries
The role ensures compliance with regulatory requirements and corporate policies, delivering timely, accurate, and compliant safety analyses and documents.
Primary Responsibilities:
Execute routine analyses and synthesize safety data into documents with minimal supervision.
Assess document requirements, gauge complexity, identify gaps, and propose solutions in collaboration with project teams.
Communicate resource and timeline needs to project teams and line management.
Ensure documents are produced in accordance with internal SOPs and external regulatory guidance.
Collaborate with subject matter experts to ensure factual, clear, and concise presentation of analyses.
Deliver documents on or before deadlines, addressing anticipated delays or quality concerns proactively.
Oversee internal or external authors when required, ensuring high-quality document delivery.
Review vendor-produced documents and evaluate vendor performance.
Understand dependencies across RMPs, DSURs, PBRERs, and ACOs for regulatory submissions.
Serve as WWS point of contact for document-related issues, if assigned.
Identify and communicate opportunities for process improvement.
Develop and maintain constructive relationships across Pfizer lines, including country organizations.
Education & Experience Requirements:
Minimum Qualifications:
Bachelor’s Degree in Life Sciences
3+ years of relevant medical experience (patient care, clinical trials, academic medicine, pharmaceutical industry)
Preferred Qualifications:
Advanced degree (MD, DVM, PharmD, Master’s/PhD in relevant field)
Skills & Attributes:
Ability to execute and interpret routine safety analyses
Strong understanding of regulatory guidance on benefit/risk communication and pharmacovigilance
Ability to synthesize aggregate or individual patient data into clear written documents
Good understanding of disease pathology and treatment approaches
Analytical problem-solving skills for moderately complex situations
Effective interpersonal and collaboration skills
Minimal supervision required for document preparation
Work Location:
On-premise – Chennai, India
Category:
Pharmacovigilance / Drug Safety
Regulatory Medical Writing
Medical Affairs – Safety & Risk Management
Gujarat :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Auckland |New Zealand :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
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