Chumnith Peter Bour Email & Phone Number

Boston, Ma, Us

North Chicago, Illinois, Us

ImmunoGen is now a part of AbbVie

North Chicago, Illinois, Us

North Chicago, Illinois, Us

Boulder, Co, Us

Panning solutions to achieve identified objectives, developing controlled documents where appropriate, interfacing with senior cross-functional leaders, and influencing decision-making in aspect of vendor oversight.Support in the assessment of PV and non-PV vendors on an ongoing basis to ensure US vendors continue to be categorized correctly to receive appropriate oversight based on the evolving scope of work between US and the corresponding vendor. Collaborate with EU PV team and contribute to the Pharmacovigilance System Master File (PSMF) as applicable to US service vendors for us.Assist in providing leadership, as applicable, supporting in daily PV vendor oversight tasks and responsibilities.Support PV vendor with the process of periodic report generation (for e.g. PADER), ensuring timely and appropriate input from PV and other departments, and approval for submission.Development and maintenance of PV SOPs and Work Instructions, working closely with PV colleagues and QA to ensure compliance with applicable global PV legislation and guidance. Maintain inspection readiness via appropriate PV compliance monitoring of US post-marketing vendors in collaboration with Global GVP Compliance colleagues.Support PV Leadership with maintaining and updating applicable project/procedural plans.Provide vendor oversight for the accurate and timely submission of ICSRs/SAEs, and aggregate reports within the US to include but not limited to:Manage the day to day activities with the vendorExecute oversight responsibilities as defined and documented in the applicable vendor oversight SOPs and associated work instructionsCoordinate and participate in vendor governance activities based on the defined oversight activities.Review/analysis of vendor partner workload distributionComplete issue identification and resolutionTrack, document and archive the oversight activities in an inspection ready formatAssist PV activities related to regulatory inspections and audits.

Bedford, Massachusetts, Us

-Vendor Management; Oversight of Case Processing, Medical Review, PQCs. Author PM-SMP, CT-SMP, and DEGs-Handling SDEA Agreements, revisions, contracts, reconciliation, -Invoice Handling, Budget Forecasting, Liason with Finance on Payment, Accruals, and Actuals-Lead Reconciliation Activities; literature, distributor agreements, line listings, PQC, and Medinfo-Safety Signal Detections and Risk Management Activities-PBRER, PADER, PSUR activities; Line listing productions, analysis, review, authoring-Extensive database knowledge; Clintrace, ARisG, and Argus-Involved with Audits, Inspections, Trainings at a global level -Author/Review/Edit CAPAs, Note to Files, Deviations-Author/Review/Edit SOPs, WI,-Direct interaction with global affiliates, QPPVs, and global distributors-QC and company comment authoring for serious cases-Extensive product pipeline knowledge-Organizer for internal/external meetings, quality/compliance, vendor operational, -Leader in database clean up activities; moving from one database to another-Leader in organization activities, paper based to solely electronic based.-Experience on both clinical trial and post marketed spectrums

Cambridge, Ma, Us

Ingelheim Am Rhein, Rhineland-Palatinate, De

Lexington, Ma, Us

Stamford, Ct, Us

Paris, France, Fr

Deerfield, Il, Us

Woonsocket, Rhode Island, Us