Job Title:
Aggregate Report Analyst – Senior Associate
Location:
Chennai, India
Employment Type:
Full-time
Job ID:
4938862
Posted Date:
12 Days Ago
Company Overview:
Pfizer is committed to breakthroughs that change patients’ lives. The organization innovates every day to advance global health and deliver life-changing medicines.
Values:
Clear expectations on achieving goals for patients
Integrity, collaboration, and scientific excellence
Position Purpose:
The PSSR Aggregate Report Analyst is responsible for creating 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 accurate, timely, and compliant safety data analyses and documents.
Primary Responsibilities:
Execute routine analyses and synthesize safety data into aggregate reports with guidance from project teams.
Assess document requirements, gauge complexity, identify information gaps, and propose solutions.
Communicate resource and timeline needs to project teams and line management.
Produce documents in line with internal SOPs and external regulatory guidance.
Collaborate with subject matter experts to ensure clear, factual, and concise presentation of analyses.
Oversee internal or external authors when necessary, ensuring timely delivery of high-quality documents.
Review and manage vendor-produced documents; evaluate vendor performance.
Understand dependencies across RMPs, DSURs, PBRERs, and ACOs for regulatory submissions.
Maintain constructive relationships across Pfizer lines and country organizations.
Identify opportunities for process improvements and communicate them to line management.
Education & Experience Requirements:
Minimum Qualifications:
Bachelor’s Degree in Life Sciences
2+ years of relevant medical experience (patient care, clinical trials, academic medicine, pharmaceutical industry)
Preferred Qualifications:
Advanced degree (MD, DVM, PharmD, Master’s/PhD in a relevant field)
Skills & Attributes:
Ability to execute and interpret routine safety analyses
Understanding of regulatory guidance on benefit/risk communication and pharmacovigilance
Strong writing skills for synthesizing data into clear, concise text
Basic understanding of disease pathology and treatment approaches
Analytical problem-solving skills for moderately complex situations
Effective interpersonal and collaboration skills
Work Location:
On-premise – Chennai, India
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