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).
Robust people and project management skills

📌 PV Lead(SJ-IQ) (Kochi)
🏢 SE MENTOR SOLUTIONS
📍 Kochi