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Patient Safety Specialist

3-5 years
Not Disclosed
10 Feb. 20, 2025
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

Patient Safety Specialist

Job ID: REQ-10037066
Date Posted: 14/02/2025
Location: India


Job Description

Your Key Responsibilities:

Your responsibilities include, but are not limited to:

  • Develop and implement oversight mechanisms for safety activities within the local Affiliate(s), including those outsourced to third-party vendors.

  • Manage pharmacovigilance activities in the Sandoz affiliate, with support from the Patient Safety Manager/Patient Safety Director of the region.

  • Influence the affiliate organization.

  • Ensure the seamless flow of safety-relevant information.

  • Maintain awareness of safety profiles of Sandoz products.

  • Establish or participate in oversight mechanisms on safety activities, including:

    • Risk Management.

    • QMS and supporting processes (trainings, record management, compliance management, audits, inspections, deviation and CAPA, Local PSMF, PV Agreements, Local Regulatory Intelligence).

    • Sandoz Patient Safety Governance.

  • Deputise countries within the APMA region.


What You’ll Bring to the Role:

Essential Requirements:

  • Professional qualification in Health Care Sciences (e.g., Pharmacist) or equivalent education.

  • Experience: Minimum 2-3 years in the pharmaceutical industry, e.g., Regulatory Affairs, Medical Affairs, Safety, or Pharmacovigilance (preferred).

  • Functional Breadth.

  • Collaborating across boundaries.

  • Operations Management and Execution.

Skills:

  • Databases.

  • Employee Training.

  • Filing (Documents).

  • Pharmacovigilance.

  • Reporting.

  • Safety Science.