Lead/Associate Manager - Case Processing1

Responsibilities:

• Thorough understanding of ICSR and/or literature monitoring processes, including all related guidelines and 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 timelines, address or 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 forthe team members.
• Support the functional capability development of team members and the Team Lead, as applicable.
• Conduct processtraining asrequired and per project needs.
• Proactively provide qualitative suggestions for improvements in processes and workstreams, leading to greater efficiencies.
• Contribute toward strengthening the business process(client/internal project workflows) and workstream-specific processes.
• Develop and maintain assigned departmental quality system procedures and 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 modules, 21 CFR guidelines, and other regulatory requirements.
• Experienced in managing high and fluctuating ICSR volumes.
• Possess strong knowledge and awareness in processing of non-serious, serious, and potentially serious ICSRs from sources such as spontaneous reports, literature, regulatory authorities, solicited reports, and clinical trials.
• Experience in rare diseases and oncology would be an added advantage.
• Experience in literature review would be an added 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.
• 1012 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