Manager - Case Processing
4 days ago
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
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