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    Aggregate Report Analyst

    Pfizer
    3+ years
    Not Disclosed
    Chennai
    10 Aug. 7, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

    Position Title: PSSR Aggregate Report Analyst

    Position Purpose: The PSSR Aggregate Report Analyst is responsible for creating documents related to post-marketing safety data to support product development, license applications, and post-marketing maintenance. This role involves generating integrated analyses of safety data for various aggregate reports, including Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), Period Benefit-Risk Evaluation Reports (PBRERs), and other regulatory and safety documents. The Analyst ensures that safety data and benefit-risk assessments are presented accurately and in compliance with regulatory requirements and corporate policies.

    Primary Responsibilities:

    • Document Preparation: Create and manage documents such as DSURs, PSURs, and other aggregate safety reports. Ensure all documents are timely, accurate, and in line with internal SOPs and external regulatory guidelines.
    • Resource and Timeline Management: Communicate resource and timeline needs for assigned documents to project team members, negotiate as necessary, and keep management informed.
    • Document Strategy: Collaborate with project team subject matter experts to develop document strategies and ensure clear, effective, and concise presentation of analyses.
    • Quality Assurance: Ensure timely delivery of high-quality documents. Alert project teams and management of any potential delays, information gaps, or quality issues.
    • Oversight and Collaboration: Oversee and review documents produced by internal or external authors and vendors. Evaluate vendor performance and maintain constructive relationships with other Pfizer lines and country organizations.
    • Process Improvement: Identify areas for process improvements and communicate potential solutions to line management or relevant functional lines.

    Technical Skills Required:

    • Writing Skills: Excellent scientific writing abilities to summarize and interpret complex data effectively.
    • Analytic Skills: Proficiency in analyzing data, formulating hypotheses, and executing analyses.
    • Oral Presentation Skills: Strong skills in presenting, explaining, and defending data analyses to internal and external audiences.
    • Language Skills: High fluency in written English and strong functional fluency in spoken English. Knowledge of additional languages is a plus.
    • Personal Skills: Strong organizational skills, ability to prioritize multiple projects, and meet deadlines.
    • Interpersonal Skills: Effective influencing and negotiating skills, ability to guide document content strategy, and work well with global, cross-functional teams. Capability to mentor junior colleagues and external vendors.
    • Regulatory Knowledge: Familiarity with global regulatory guidance (e.g., ICH, FDA, EMA) relevant to clinical and safety data.
    • Software Proficiency: Experience with data presentation and analysis software (e.g., Word, PowerPoint, Excel) is preferred.
    • Statistics and Epidemiology: Proficiency with statistical concepts and epidemiological principles is desirable.

    Qualifications:

    • Education: Bachelor’s Degree in life sciences with 3+ years of relevant medical experience, including patient care, clinical trial experience, academic medicine, or pharmaceutical industry experience. Advanced degrees (MD, DVM, PharmD, or Master’s/PhD) are preferred.
    • Experience and Attributes:
      • Ability to execute and interpret routine safety analyses with guidance.
      • Comprehensive understanding of regulatory guidance related to benefit/risk presentation and pharmacovigilance.
      • Capability to synthesize aggregate or individual patient data into clear, written text with minimal supervision.
      • Strong understanding of medical concepts related to diseases and treatments.
      • Decision-making skills for resolving moderately complex problems.

    Work Location: Flexible

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction where it operates.

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