• Lead and manage the project to comply with the SOW and SLAs.• Supervise all project related activities.• Single point of contact between the team and the client for smooth functioning of the project.• Communicate between the management and the team.• Record, maintain and track the metrics for both team members and project performance.• Provide guidance for Data entry. • Train and mentor new team members as per requirements of the project.• Act as a management level liaison between Client and Qinecsa Project team• Coordinate and manage administrative project issues• Delegate tasks and responsibilities to appropriate personnel• Identify and resolve issues and conflicts within the project team• Recruit, select and train team members• Act as guide, coach and counselor for the team• To prepare and discuss RCA/CAPA as or when required.• To prepare and discuss weekly and monthly metrics report. • Attended client audit and provided inputs for respective team.

1. Supervise pharmacovigilance case processing team in accordance with customer’s as well as organization’s policies and guidelines.2. Responsibilities also include planning, assigning, and directing work, performance appraisal and professional development guidance and addressing employee relations issues and resolving problems.3. Manage the case flow process across the team to ensure timely and accurate processing of ICSRs from different sources – Spontaneous, Solicited, Literature articles, Clinical Studies and Medical device etc.4. Manage available resources to ensure effective processing of workload.5. Responsible for overall performance of team and meeting all SLAs as per the business agreement.6. To ensure 100% compliance on submission of adverse drug reports to the Regulatory Authorities and Licensing Partners.7. To provide regular feedback to the case processors and QAs on different case scenarios as well as based upon feedback received from clients and Medical Reviewers.8. Take responsibilities for implementing the corrective actions resulting from timeliness or quality issues related to the case processing.9. Support the organization and management in audit and inspection readiness activities. Also participated in client audits.10. Prepare and discuss weekly and monthly metrics with the client.11. To provide resolution to Client as well as licensing partner queries.12. To draft RCA and CAPAs in case of any deviation as per the business agreement.13. User Acceptance Test (UAT) script preparation during database upgrade.14. Contribute to the initial draft of pharmacovigilance policies, SOPs, Working Instructions (WINs).15. Working closely with the users to ensure the project needs business needs.

Responsible to manage different queues of Pharmacovigilance Case Processors and Peer Reviewers (QAs) and to ensure the deliverables of PV activity within defined timelines.Worked as Assistant Project Manager for two ramp projects and delivered all assignments on time.Worked with the Business Development/Pre Sales team for new business ventures.Preparation of Business Case Study for new business proposals.Keeping a close view on daily activity of the team and data provided by the Team Leaders of the respective queues.Planning for the week in advance with Team Leaders and Trainer to continue the smooth work.Working on monthly Bottom Quartile Management (BQM) based on productivity and quality to identify the bottom performers and preparing action plan for their improvement.Weekly meeting with the team Leader and Trainers of different queues to discuss weekly performance of the team and making action plan for the next week.Get involved with the other internal departments and support functions to work upon new SOPs and planning of any internal approach notes.Worked with the Project Quality Manager to ensure completion of all training assigned by the customer on time and prepare plan for quality improvement.Preparation and presenting MBR (Monthly Business Review) Call.Preparation of RCA/CAPA if asked by the customer on any error done by the team.Recruitment interview for new hires.Annual Appraisal for the team as part of Operations.

Handled team of Pharmacovigilance case processors with optimum level of employee/management satisfaction.Work allocation among the team. Forecasting and planning on daily basis to ensure the availability of bandwidth to handle additional work if required.To ensure completion of assigned work within Turnaround time (TAT) limitations as per the business agreement.To ensure all Service Levels (SL’s) are met as per the business agreement.Take immediate action in case of any quality observations from customer side.Giving feedback to the team on typical case scenarios with proper sign offs.To keep a track on queries/escalation emails from primary reviewer or medical reviewer and respond immediately.Taking team meetings on weekly basis to discuss the people issues and provide work related updates.Prepare and submit Corrective And Preventive Action (CAPA) if any asked by the customer.Preparing and attending Monthly Business Review (MBR).Collating and forwarding monthly case tracker to the central team for billing purpose.Interacting with the internal quality team on weekly basis and giving them update about the quality of work.Capacity planning with the Central Work Force Management (CWFM) Team and get involved with hiring of new people.Interacting with the trainer/facilitator team at customer side to give them updates regarding new hires and their training requirements in Argus safety database.Assigning mentors for new hires and ensuring the mentorship activity is being done by all assigned mentors on daily basis.Interacting with other support functions e. g HR team, Technology team, Facility management group (FMG), Transport team for any kind of people issue and ensure resolution.Planning and making roster for the team as per the business requirements and forecasting.

Quality Analysis of processed casesEnsuring correctness of data entryVerify drug coding through CDD or WHO drug dictionariesVerify medical history, product indications, adverse events through MedDRA limitationsRemoving E2B errors from the caseVerify different case scenarios by referring different case related SOPs/guidelinesVerify HCP/Non-HCP follow-up letters, other company notification and notification to License PartnersRoute the case to appropriate workflow after Quality ReviewTo mentor and guide the case processing team from a QC perspective.

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.Listedness and Causality Assessment.Create new case number in Argus database by Splitting based on scenario

Interfacing with individuals / key influencers among Corporates, Distributors, Medical fraternity & Doctors for ascertaining requirements & delivering need based product solutions.Taking care of the Sales & Marketing operations with focus on achieving sales growthMaintaining excellent relations with clients to generate avenues for further businessAlways achieved monthly sales targetDid market research also to compare the sale of Pfizer products and potential competitorsTwo times selected for “hot photon” monthly news letter of Pfizer India teamConducted doctor’s meeting to promote the productsIncreased the monthly sales target and revenue by almost 3 folds in a span of 9 months.