Team Lead - CSPV

Soterius, Inc.; Dadri; On-site; INR 600,000 - 900,000; Full time

Job summary

Soterius, Inc. is looking for a qualified professional to lead pharmacovigilance projects in Dadri, India. The ideal candidate will ensure compliance with regulatory requirements and manage project timelines while providing mentorship to team members.

This role involves detailed project management, quality assurance, and collaboration with stakeholders. Strong knowledge in pharmacovigilance is essential along with strong communication and organizational skills.

Qualifications

• Knowledge of pharmacovigilance and regulatory requirements of key regulatory authorities.
• Ability to work independently with minimal supervision.
• Proven experience in team handling, including mentoring and performance management.

Responsibilities

• Ensure the effective functioning of PV projects in compliance with regulations.
• Take ownership of assigned projects ensuring adherence to timelines.
• Manage quality, compliance, and documentation across PV projects.

Skills

Knowledge of pharmacovigilance

Strong communication

Time management skills

Team handling experience

Job description

Qualifications:

• Knowledge of pharmacovigilance and regulatory requirements of key regulatory authorities.
• Ability to work independently with minimal supervision.
• Strong communication and time management skills.
• Proven experience in team handling, including mentoring, performance management, and task delegation.

Key Responsibilities:

• Ensure the effective functioning of pharmacovigilance (PV) projects in compliance with client agreements and applicable regulations/guidelines.
• Take ownership of assigned projects and tasks, ensuring adherence to timelines and quality standards.
• Manage quality, compliance, and documentation across PV projects.
• Alert the functional head/designate regarding any personnel management concerns that may impact work quality or functioning.
• Collaborate continuously with internal and external stakeholders to ensure compliance with agreements, regulations, and guidance.
• Train and mentor personnel as needed.
• Identify and address training and development needs relevant to the function.
• Represent the department/function during audits and inspections.
• Author and review SOPs and other relevant documents as assigned by Management.
• Monitor and manage departmental workload, escalating concerns to the functional head/designate when necessary.
• Provide line management for assigned personnel as designated by Management.
• Perform other responsibilities as assigned by Management.