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Safety Surveillance Associate

0-2 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

Job Title: Pharmacovigilance Case Processor (Hybrid)

Position Purpose: The primary responsibility of this role is to review, prepare, and complete reports of adverse drug experiences in order to determine 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 reasons for delays.
  • Assess cases with particular complexities and escalate them as appropriate.
  • Review, rank, verify, and process event terms, case classifications, product complaints, reportability, and accuracy of cases.
  • Determine appropriate workflow for case processing based on case criteria.
  • Write and edit case narratives accurately.
  • Generate regulatory-compliant reports and ensure timely submission.
  • Handle follow-up actions, requesting follow-up letters when necessary.
  • Collaborate with key stakeholders such as Pfizer Country Organizations, Clinical Development, License Partners, and others regarding safety data collection and reconciliation.
  • Maintain knowledge of Pfizer's product portfolio, global regulations, and Standard Operating Procedures (SOPs).
  • Consistently apply regulatory requirements and Pfizer policies.

Technical Skill Requirements:

  • Experience in pharmacovigilance, clinical care, or research is advantageous but not required.
  • Proficiency with relational databases and computer systems.
  • Ability to meet departmental performance standards while achieving personal objectives.
  • Capacity to work effectively under supervision in a matrix organization.
  • Strong oral and written communication skills.
  • Fluency in English (additional languages are a plus).
  • Experience in medical writing is a bonus.

Qualifications:

  • 0-4 years of experience in Pharmacovigilance, Clinical Research, Hospital Practice, Teaching, or related fields.
  • A minimum of a bachelor’s degree in a healthcare-related field (e.g., Dentistry, Pharmacy, Nursing, or equivalent).

Work Location: Hybrid

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