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Senior Safety Surveillance Associate

4-6 years
Not Disclosed
10 Nov. 13, 2024
Job Description
Job Type: Full Time Remote 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

Position Title: Pharmacovigilance Case Processor (Hybrid)
Reports To: Case Processing Team Lead
Position Purpose: Review, prepare, and complete reports on adverse drug experiences to assess the safety profile of Pfizer’s products and ensure regulatory compliance.

Primary Responsibilities:

  • Identify and select routine cases for processing, prioritize based on criteria, and document any delays.
  • Assess and flag complex cases for escalation.
  • Review, classify, verify, and process event terms, case classifications (validity, seriousness, expectedness/listedness/labeledness), special scenarios, product complaints, and reportability.
  • Follow appropriate case processing workflows based on case review.
  • Write and edit case narratives accurately.
  • Generate and submit reports in compliance with regulatory timelines.
  • Follow up on cases as necessary and request follow-up letters when needed.
  • Collaborate with Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders on safety data collection and reconciliation.
  • Maintain in-depth knowledge of Pfizer's product portfolio, regulations, guidelines, and safety database tools.
  • Consistently adhere to regulatory requirements and Pfizer policies.

Technical Skills:

  • Experience in pharmacovigilance, clinical care, or scientific research is preferred but not required.
  • Strong computer skills, especially in managing relational databases.
  • Ability to meet personal and departmental objectives.
  • Ability to work in a matrix organization with supervision.
  • Strong oral and written communication skills.
  • Fluency in English is required; knowledge of additional languages is a plus.
  • Medical writing skills are an advantage.

Qualifications:

  • 4-6 years of experience in pharmacovigilance.
  • A minimum of a bachelor’s degree in healthcare (e.g., dentistry, pharmacy, nursing, or equivalent).

Work Location: Hybrid

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