PV Lead(SJ-IQ)

SE Mentor Solutions; Ernakulam; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

SE Mentor Solutions seeks an experienced Pharmacovigilance Lead to oversee an offshore project team delivering support for global PV initiatives. The role emphasizes timely AE/PQC identification and documentation in line with client SOPs, while ensuring regulatory compliance and high-quality deliverables.

The candidate should bring 8–10 years in PV, proven leadership, and hands-on experience with offshore delivery and PV systems like ARGUS, to drive continuous improvement across cross-functional

Qualifications

• 8-10 years of experience in Pharmacovigilance with strong AE and PQC reporting.
• Proven leadership in managing projects and building high-performing PV teams.
• Hands-on experience with global PV projects and offshore delivery models.
• Familiarity with PV databases and ARGUS.

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) per client SOPs.
• Ensure regulatory compliance.
• Provide strategic leadership and direction to the project team, fostering excellence and continuous improvement.
• Collaborate with cross-functional teams to integrate PV activities with other functions.
• Develop and implement PV processes to enhance efficiency and effectiveness.
• Monitor and evaluate team performance, providing coaching and development opportunities.
• Stay updated with PV regulations and industry best practices.

Job description

• 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

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

Education/Qualification

• HCPs (M Pharma/MBBS/BDS..) are preferred

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)

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