Manager - Case Processing

4 days ago

Bengaluru, Karnataka, India ClinChoice Full time ₹ 8,00,000 - ₹ 24,00,000 per year

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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