Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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.