PV Lead(SJ-IQ)
SE-Mentor Solutions (P) Ltd · Not specified · onsite · Posted 59d ago
Not disclosed8–10 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
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
- HCPs (M Pharma/MBBS/BDS..) are preferred
- 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)
- 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
Sourced from foundit
Skills
PV databasespharmacovigilanceArgusMedDRA codingICSR case processingGCP guidelinesICH regulations