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Pharmacovigilance Manager - 100% Remote, Based In India

0-2 years
Not Disclosed
10 Dec. 19, 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 Manager (100% Remote - India)
Company: Alphanumeric
Job Type: 9-Month Temporary Contract (with possibility of extension)
Location: 100% Remote (India, with business hours in London)
Start Date: As soon as possible
Salary: Competitive

Job Purpose:
Support Pharmacovigilance Operations (PV Ops) with ICSR Management for a leading global pharmaceutical brand.

Key Responsibilities:

  • Oversee creation, maintenance, and archiving of written standards for ICSR Management.
  • Drive high-quality documentation and ensure compliance with internal and external regulations.
  • Facilitate investigation of identified issues and create corrective/preventative actions (CAPAs).
  • Collaborate across a complex matrix environment to enhance PV Ops methodologies.
  • Build relationships with external stakeholders and senior leaders.
  • Provide guidance and support to the ICSR Management team, ensuring adherence to SOPs and regulations.
  • Identify training needs and collaborate with the training team to create necessary plans.
  • Offer strategic advice on written standards, processes, and procedures.
  • Mentor new staff during onboarding and drive innovation across PV Ops.

Education Requirements:
Degree in life sciences or a related field, or equivalent experience.

Experience:

  • Proven experience in process development and maintenance of written standards (SOPs, Work Instructions, etc.).
  • Knowledge of pharmacovigilance systems and experience in mapping processes.