Lead/Associate Manager - Case Processing1 at ClinChoice

Bengaluru, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

11 Jan, 26

Salary

0.0

Posted On

13 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

ICSR, Literature Monitoring, GVP Modules, 21 CFR Guidelines, Pharmacovigilance, Case Processing, MedDRA Coding, Training, Team Management, Process Improvement, Risk Mitigation, Quality Assurance, Performance Management, Operational Efficiency, Clinical Trials, Rare Diseases, Oncology

Industry

Pharmaceutical Manufacturing

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

Responsibilities

The Lead/Associate Manager is responsible for overseeing ICSR and literature monitoring processes, ensuring tasks are assigned to meet deliverables according to SLAs and KPIs. They will also conduct performance management and support the development of team members while suggesting process improvements.