Skills

Result oriented professional with 6+ years of strong background in Operations, Client management, Compliance, Audits, Team management in the field of patient safety and Pharmacovigilance.

• • Key Skills:
    • Service Delivery, Client Services, Business Excellence, Transition Management, Business Transformation Initiatives
    • Project management, Performance management, Data management, Validation, SOP management, Compliance, Recruitment and Training, Text Analytics.
    • Analytical thinking, decision making, problem solving skills and strong leadership capabilities.
    • Strategic planning, organizing and execution.
    • Knowledge of Office Package: - Microsoft Word, Microsoft Excel, Microsoft PowerPoint and Microsoft Outlook Express.
    • Knowledge about Argus, ICH guidelines, ICSR and safety reporting.
    • Lean and Six Sigma green belt certified.
• Professional Experience:
  • Assistant Manager (Quality Lead) at Wipro Limited [September 2017 – Present]
  • • Responsible for achieving the project SLA levels of On Time, Quality and Audits.
    • Business planning, forecasting.
    • To drive PIP (performance improvement plans) for continual improvement and process efficiencies. Ensure continuous process improvement through effective implementation of organizational Quality Management System (QMS).
    • Client handling to exceed client expectations.
    • Active participation in rewards and recognition programs.
    • Leading quality based initiatives using lean, six sigma quality methodologies.
    • Active participation in RFP/RFI responses and solution design.
    • Risk assessment and analysis, review of BCP and DRP.
    • Manage internal and external audits.
    • RCA and CAPA management, calibrations activities.
    • Periodic reviews of FMEAs (Failure Mode Effect Analysis) to identify potential risks and come up with the resolution to mitigate risks.
  • Team Leader (Quality Lead) at Wipro Limited [November 2015 – September 2017]
  • • Generate QA reports and manage QA dashboard.
    • Drafting/periodic review of Quality Management plan, client feedback tracker along with its compliance by the operations and quality team.
    • Preparation, Revision and Training of the Standard Operating Procedures (SOPs) for the various functions of the process.
    • Ensuring compliance across, adherences to the policies and professional conduct. Collaborates with other departments (e.g. Operations, HR, Training and other departments) to direct compliance issues to appropriate existing channels for investigation and resolution
    • Spear head process initiatives and projects and overlook training requirements across process.
    • Prepare monthly quality reports/dashboards pertaining to performance and Quality.
    • Provide fortnightly presentations to operations team regarding the key areas of defects and performance of associates through Pareto analysis.
    • Conduct periodic random audit of the training files to ensure its compliance as per the client and organization SOP’s.
    • Review case processing through random audits, share observations and prepare Action Plans.
    • Conduct quality awareness sessions for entry level associates.
  • Quality Analyst at Wipro Limited [June 2014 – November 2015]
  • • Auditing of cases per guidance documents ensuring high standard of Quality.
    • Work allocation and prioritization of cases in order to smooth work flow of cases within the regulatory reporting timelines to avoid late reporting of cases.
    • Provide feedback and updates to the associates for improving the quality of work.
    • Quality Check of the recorded calls and the ADR form.
    • Communicate issues pertaining to Product Quality Complaint (PQC\\\\\\\'s), Medical Enquiries.
  • Pharmacovigilance Officer at Wipro Limited [June 2013 – June 2014]
  • • Interacting directly with patients and healthcare professional over the call and documenting the ADR\\\\\\\'s (Spontaneous ADR\\\\\\\'s).
    • Processed the Individual Case Safety Reports (ICSR) from different sources i.e. Literature, Spontaneous, Marketing Program, Product Quality Complaint Group, Health Authority and various Licensee Parties in the Pharmacovigilance database (ARGUS).
    • Initial Data Entry (Book-in) of case reports into Safety Database. Assessment of case reports into safety database.
    • Med DRA and WHO coding.
    • Follow-up with patients/consumers and healthcare providers regarding queries. Writing and updating case narratives.

Time and Spatial Flexiblity

Valid CANADIAN PR

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