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Associate I, Safety Data Management Specialist

2+ years
Not Disclosed
10 Nov. 13, 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, CPC Certified, 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

Why Patients Need You

At Pfizer, Worldwide Medical and Safety teams play a vital role in connecting evidence-based medical decision support to colleagues and stakeholders, ensuring better health and treatment outcomes. Our mission is clear: Empower healthcare decisions about the safe and effective use of medicines, closing data gaps, ensuring scientifically sound evidence, and providing unbiased medical expertise for patients.

What You Will Achieve

As a Senior Associate, you will be entrusted with monitoring Pfizer's drug, biologics, and medical device surveillance programs. This includes intake, evaluation, and processing of adverse reports, alongside supporting both clinical trials and post-marketing activities.

Your knowledge and expertise will be key in achieving the team’s goals and completing important deliverables on time. You will effectively leverage communication tools and techniques to manage complex issues and facilitate consensus-building across teams. Your dedication ensures that Pfizer’s customers and patients receive the medicines they need promptly and safely.

How You Will Achieve It

  • Contribute to the completion of complex projects by managing time effectively, meeting deadlines, and developing plans for individual project activities.
  • Provide team oversight and mentoring on case handling, data extraction, analysis, and follow-up activities.
  • Act as a subject matter expert, collaborating with key partners to ensure accurate safety data collection and reconciliation.
  • Review, analyze, and prepare safety-related reports, contributing to determining the safety profile of Pfizer's products in line with regulatory requirements.
  • Verify the accuracy, consistency, and compliance of processed cases and review special case scenarios.
  • Where applicable, manage safety resources within the local team.
  • Offer pharmacovigilance or product-specific expertise, mentoring colleagues to enhance knowledge.
  • Maintain in-depth knowledge of Pfizer's product portfolio, applicable corporate policies, and safety regulations.
  • Design, track, and report on relevant safety metrics to monitor performance.
  • Ensure deadlines are met through effective project and process management.
  • Conduct database searches to support safety data tracking and reporting.

Qualifications

Must-Have:

  • Bachelor's Degree
  • 3+ years of relevant experience
  • Strong organizational and project management skills
  • In-depth understanding of global drug development regulations and guidelines
  • Proficient in analytical and statistical methods
  • Independent decision-making with an ability to resolve complex issues
  • Strong productivity, organizational, and time management skills to meet strict regulatory compliance goals
  • Fluent in both spoken and written English

Nice-to-Have:

  • Master’s degree
  • Relevant pharmaceutical industry experience
  • Familiarity with performance metrics management
  • Proven ability to handle complex and unique situations independently and make sound decisions to achieve desired outcomes

Pfizer is an equal opportunity employer and adheres to all applicable equal employment opportunity legislation in each jurisdiction in which it operates.