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Assistant Manager Case Processing

2 weeks ago

Noida, Uttar Pradesh, India PharmaLex Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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Job Details

  • Performing triage and review for initial validity assessment of cases including spontaneous, health authority, Clinical Trial and literature cases.
  • Responsible for quality management, workload management, compliance management and document management for the assigned PV projects
  • Evaluation of the need for expedited reporting to Health Authorities / partners of a client concerned, including reporting timelines
  • Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files)
  • Preparation and sending of follow‐up requests
  • Submission of ICSRs to Health Authorities and partners of a client
  • Acts as line manager of assigned staff
  • Manages project coordination and resource allocation within the projects
  • Train and mentor PV department staff, as needed
  • Ensures monthly invoices are generated and shared for all PV clients on regular/monthly basis
  • Responsible for recruitment of new staff in PV Department
  • Ensures all departmental CVs, job descriptions and training records are complete and up to date and as per SOPs
  • Is involved in goal setting and annual appraisals of staff
  • Participate in the goal-setting process and conduct annual appraisals for staff, providing constructive feedback and support to foster individual development and align team objectives with organizational goals.
  • Ensures training compliance by PV staff at all times
  • Represents PV department during for-cause/maintenance client audits or regulatory authority inspections
  • Ensure compliance with internal standards and external (national and international) regulations
  • To write/ review QA documents such as SDEA's, Working Instructions, SOPs, Working Procedures, templates, project metafiles etc. for PharmaLex Pharmacovigilance projects
  • To organize and perform training of the above-mentioned documents
  • Case processing including data entry and QC
  • Case completion / documentation.
  • Actively mentor and support new joiners by providing guidance on company processes, facilitating their integration into the team, and fostering a collaborative learning environment to enhance their professional development.
  • Responsibilities will be assigned by the supervisor in accordance with process requirements.
  • Performing triage and review for initial validity assessment of cases including spontaneous, health authority, Clinical Trial and literature cases.
  • Responsible for quality management, workload management, compliance management and document management for the assigned PV projects
  • Evaluation of the need for expedited reporting to Health Authorities / partners of a client concerned, including reporting timelines
  • Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files)
  • Preparation and sending of follow‐up requests
  • Submission of ICSRs to Health Authorities and partners of a client
  • Acts as line manager of assigned staff
  • Manages project coordination and resource allocation within the projects
  • Train and mentor PV department staff, as needed
  • Ensures monthly invoices are generated and shared for all PV clients on regular/monthly basis
  • Responsible for recruitment of new staff in PV Department
  • Ensures all departmental CVs, job descriptions and training records are complete and up to date and as per SOPs
  • Is involved in goal setting and annual appraisals of staff
  • Participate in the goal-setting process and conduct annual appraisals for staff, providing constructive feedback and support to foster individual development and align team objectives with organizational goals.
  • Ensures training compliance by PV staff at all times
  • Represents PV department during for-cause/maintenance client audits or regulatory authority inspections
  • Ensure compliance with internal standards and external (national and international) regulations
  • To write/ review QA documents such as SDEA's, Working Instructions, SOPs, Working Procedures, templates, project metafiles etc. for PharmaLex Pharmacovigilance projects
  • To organize and perform training of the above-mentioned documents
  • Case processing including data entry and QC
  • Case completion / documentation.
  • Actively mentor and support new joiners by providing guidance on company processes, facilitating their integration into the team, and fostering a collaborative learning environment to enhance their professional development.
  • Responsibilities will be assigned by the supervisor in accordance with process requirements.

**What Cencora offers****
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

**Affiliated Companies****
Affiliated Companies: PharmaLex India Private Limited

*Equal Employment Opportunity*
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call or email We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned