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Manager - Pharmacovigilance

Adaptis Pharma
Adaptis Pharma
8-12 years
Not Disclosed
10 July 29, 2024
Job Description
Job Type: Full Time Education: M. Pharm, MBBS, or MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Position: Manager - Pharmacovigilance

Education Requirements:

  • M. Pharm, MBBS, or MD

Experience:

  • 8-12 years of proven success in pharmacovigilance

Job Description:

  • Lead the pharmacovigilance team at Adaptis
  • Oversee PV planning, resource management, and project execution
  • Manage timelines and deliverables
  • Ensure a highly compliant Pharmacovigilance (PV) system
  • Stay updated on local and global PV processes and regulations
  • Lead and coordinate PV audits and inspections
  • Monitor PV system performance and partner compliance
  • Handle all strategic PV activities for Adaptis
  • Ensure monitoring of client product safety profiles to meet regulatory requirements
  • Act as the primary contact for safety-related aspects and PV in the region
  • Maintain thorough documentation of internal PV processes and procedures

Skills and Requirements:

  • In-depth knowledge of national and international PV legislation and guidelines
  • Ability to deliver high-quality work in cross-functional teams
  • Strong organizational and interpersonal skills
  • Experience in managing outsourced vendor activities in a regulated field
  • Proficient in troubleshooting and managing multiple projects concurrently
  • Excellent verbal and written communication skills

Location: Pune

Contact: info@adaptisls.com

Website: www.adaptisls.com