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Pharmacovigilance Auditor

0-2 years
Not Disclosed
10 Dec. 18, 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

Pharmacovigilance Auditor
Location: Bluefish Pharmaceuticals
Job Category: Pharmacovigilance

About Bluefish Pharmaceuticals:

Bluefish Pharmaceuticals, founded in Sweden, is a leading generics pharmaceutical company that strives to make quality medicines accessible to more people. We create value throughout the pharmaceutical value chain, from development to manufacturing and marketing, offering a broad range of high-quality generics across major therapeutic areas. Our strategy focuses on providing innovative, cost-efficient, and affordable products, expanding our market reach both in Europe and globally.

Role Overview:

Bluefish is looking for a Pharmacovigilance Auditor to lead and perform audits focused on Pharmacovigilance (PV) activities. The position will report to the Head of Pharmacovigilance and is open to candidates based in Bangalore, India; Stockholm, Sweden; or any Bluefish affiliate office.

Key Responsibilities:

  • Global PV Risk-Based Strategy: Maintain the global pharmacovigilance risk-based strategy for audits and risk assessments.
  • Audit Leadership: Lead, plan, and conduct both internal and external Good Pharmacovigilance Practice (GVP) audits.
  • Audit Programme Management: Oversee the annual PV audit program, ensuring that audits are conducted effectively.
  • CAPA Follow-Up: Track the development, implementation, and completion of corrective and preventive actions (CAPA) with auditees.
  • Quality Documentation: Ensure the maintenance of required quality documentation and adherence to applicable regulations.
  • Compliance Management: Ensure that Standard Operating Procedures (SOPs) and Work Instructions (WINs) are compliant with regulatory requirements.
  • Support to QPPV: Provide support to the Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU.

Candidate Specifications:

Education & Experience:

  • Bachelor’s or Master’s degree in life sciences (e.g., B.Pharm, M.Pharm).
  • Minimum of 5+ years in PV operations with at least 2+ years conducting audits within PV.
  • Strong computer skills, particularly with Microsoft Office Suite.
  • Excellent interpersonal and communication skills.

Skills & Abilities:

  • In-depth understanding of pharmacovigilance requirements.
  • Expertise in audits, CAPA management, and change management processes.
  • Strong attention to detail and highly organized.
  • Excellent written and verbal communication skills.
  • Ability to engage in personal development through self-learning.

Apply Now:

Interested candidates should send their resumes to hr@bluefishpharma.com.