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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Aggregate Report Analyst

Job Description

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