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Patient Safety Specialist

2-3 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:

As a Patient Safety Specialist, your responsibilities include, but are not limited to:

  • Oversight Mechanisms:

    • 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 and Communication:

    • Influence the affiliate organization to ensure compliance and safety standards.

    • Ensure the seamless flow of safety-relevant information across teams.

    • Maintain awareness of the safety profiles of Sandoz products.

  • Safety Activities Oversight:

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

      • Risk Management.

      • Quality Management System (QMS) and supporting processes such as:

        • Training.

        • Record Management.

        • Compliance Management.

        • Audits and Inspections.

        • Deviations and Corrective and Preventive Actions (CAPA).

        • Local Pharmacovigilance System Master File (PSMF).

        • PV Agreements.

        • Local Regulatory Intelligence.

      • Sandoz Patient Safety Governance.

      • Deputizing for countries within the APMA region as required.


What You’ll Bring to the Role:

Essential Requirements:

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

  • Minimum 2-3 years of experience in the pharmaceutical industry, including but not limited to Regulatory Affairs, Medical Affairs, Safety, or Pharmacovigilance (preferred).

Functional Breadth:

  • Ability to collaborate across boundaries.

  • Strong operations management and execution skills.

Technical Skills:

  • Proficiency with pharmacovigilance databases.

  • Employee training and development.

  • Document filing and management.

  • Safety science and risk management.

  • Accurate and timely reporting.


If you are passionate about ensuring patient safety and contributing to a global pharmaceutical leader, we invite you to apply for this exciting opportunity!

Sandoz - Reimagine Medicine. Transform Lives.