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Lead / Associate Manager - Case Processing1

Lead / Associate Manager - Case Processing1

ConfidentialBengaluru / Bangalore, India
22 days ago
Job description

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.
  • 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
  • Skills Required

    Ms Office Applications

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    Manager • Bengaluru / Bangalore, India

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