PV Lead in Trivandrum | ITJOBCELL

PV LEAD
  • 0 Applied
  • 10
  • Trivandrum
  • 6 - 0 Years
  • Not disclosed
  • PV Lead
  • Today
Job Description
Location: Kochi Experience: - 8-10 years of experience in Pharmacovigilance, with a strong understanding of AE and PQC identification and reporting - Proven leadership experience in managing projects and developing high-performing teams - Hands on experience working on global PV projects and offshore delivery model - Familiarity with PV databases and system (ARGUS) Education/Qualification: - HCPs (M Pharma/MBBS/BDS..) are preferred Key Responsibilities: - Lead and manage the offshore project team to ensure high-quality support for global PV projects - Manage the identification and documentation of Adverse Events (AEs) and Product Quality Complaints (PQCs) as per the client SOPs and guidelines - Ensure compliance with regulatory requirements - Provide strategic leadership and direction to the project team, fostering a culture of excellence and continuous improvement - Collaborate with cross-functional teams to ensure seamless integration of PV activities with other business functions. - Develop and implement PV processes and procedures to enhance efficiency and effectiveness - Monitor and evaluate team performance, providing coaching and development opportunities - Stay updated with the latest PV regulations and industry best practices
Skills
Preferred Skills: - Excellent communication and interpersonal skills - Strong analytical and problem-solving abilities - Ability to work effectively in a global, cross-functional environment - Knowledge of GCP guidelines and ICH regulations - Experience with MedDRA coding and ICSR case processing (added advantage). - Strong people and project management skills

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