Manager - Case Processing

Responsibilities:

• Thorough understanding of ICSR and /or literature monitoring process including all related guidelines/regulations.
• Provide required guidance and support as applicable to the Team lead and SMEs on operational and domain aspects as necessary.
• Ensure tasks are assigned to the team members to meet deliverables in accordance with SLAs and KPIs.
• Work closely with the team and client (as applicable) to identify and mitigate risks to meet the timelines, address/seek clarity for queries, if any and escalate when necessary
• Ensure that all assigned goals (e.g., utilization and efficiency) are met for self and team as set for the performance year.
• Conduct performance management for the team
• Support in the functional capability development of team members and Team lead as
• Conduct process training as required and per project
• Proactively provide qualitative suggestions for improvements in process and workstreams leading to greater efficiencies.
• Contribute towards strengthening of the business process (client /internal project workflows) / workstream specific processes.
• Develop and maintain assigned departmental quality system procedures, instructions and provide training as necessary both within and outside the department.

Relevant experience related to Job/Function: 

• Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
• People management
• Project management
• Client facing experience
• Experience in managing high ICSR volume/Fluctuation in ICSR volume
• Possess strong knowledge and awareness in processing of non-serious, serious and potentially serious ICSR from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
• Training and mentoring skill (ICSR, GVP Modules, MedDRA)
• Experience in Rare disease and Oncology
• Training and mentoring skill (ICSR, MedDRA)
• Experience in Literature review would be a value
• Must have hands on experience with MS office applications

Candidate’s Profile:

• Master’s degree in Life Sciences/Pharmacy/Medicine or above, aligned with project and business team requirements.
• 10–12 years of relevant experience in pharmacovigilance/case processing, or related functional domains.
• Experienced in training, guiding, and mentoring teams in ICSR processing, MedDRA coding, and GVP modules, with proven ability to support management activities in line with process requirements.
• Skilled in managing and allocating team resources effectively according to project requirements, ensuring timely and quality deliverables.
• Proactive in suggesting process improvements and strengthening workflows for operational efficiency