Lead/associate Manager - Case Processing1 Job in Clinchoice

Lead/Associate Manager Case Processing 1

Location: Bengaluru

Employment Type: Full-Time

About the Role

We are seeking a dynamic and experienced Lead/Associate Manager Case Processing to join our Pharmacovigilance team in Bengaluru. This role requires deep domain knowledge, leadership capability, and hands-on experience in handling Individual Case Safety Reports (ICSRs) across various sources. The ideal candidate will be responsible for managing day-to-day operations, ensuring compliance with global regulatory requirements, and mentoring a team of case processors.

Key Responsibilities

Operational Oversight

• Oversee and ensure the timely processing of ICSRs in accordance with SLA/KPI metrics.
• Allocate tasks effectively across the team to meet project deliverables and workload requirements.
• Proactively monitor team performance and work closely with team members to resolve operational or domain-related challenges.

Risk & Issue Management

• Identify, escalate, and mitigate risks related to deliverables, compliance, or resourcing.
• Serve as a point of contact for internal stakeholders and clients regarding operational queries or escalations.

Team Leadership & Performance Management

• Conduct regular performance evaluations, provide constructive feedback, and support career development of team members.
• Guide and mentor the team and Subject Matter Experts (SMEs) in ICSR processes, compliance standards, and MedDRA coding.
• Support functional capability development within the team and leadership pipeline.

Training & Quality Assurance

• Conduct process and project-specific training as needed to ensure team competence and readiness.
• Ensure adherence to quality standards by contributing to quality system documentation, SOPs, and procedural updates.
• Provide feedback and suggestions to strengthen client/internal workflows and ensure continuous improvement.

Process Improvement & Strategic Contribution

• Suggest and implement process enhancements to improve efficiency, accuracy, and compliance.
• Contribute to the development of scalable and sustainable pharmacovigilance processes.
• Collaborate cross-functionally to support strategic goals and business growth initiatives.

Required Experience & Knowledge

• In-depth understanding of ICH-GCP, GVP modules, 21 CFR, and relevant global regulatory requirements.
• Proven expertise in managing high-volume ICSR workloads, including serious, non-serious, and potentially serious reports.
• Experience processing ICSRs from diverse sources: spontaneous, literature, solicited, regulatory authorities, and clinical trials.
• Exposure to therapeutic areas such as rare diseases and oncology is highly desirable.
• Experience in literature screening and review would be an added advantage.
• Proficient in MS Office applications (Excel, Word, Outlook, PowerPoint).

Candidate Profile

• Education: Master s degree in Life Sciences, Pharmacy, or Medicine (or higher), aligned with project requirements.
• Experience: 10 12 years of relevant experience in pharmacovigilance, case processing, or related functions.
• Strong leadership skills with a proven ability to train, mentor, and manage cross-functional teams.
• Demonstrated ability to allocate resources, manage competing priorities, and maintain high-quality standards.
• Proactive, process-driven mindset with a commitment to continuous improvement and regulatory compliance.

Why Join Us?

• Work with a global leader in drug safety and pharmacovigilance services.
• Lead high-performing teams and contribute to the delivery of impactful healthcare solutions.
• Be part of a collaborative environment that values innovation, learning, and operational excellence.

Apply now to lead meaningful work that impacts patient safety around the world.