Rohan Pirangute Email & Phone Number

Oakville, Ontario, Canada

Lead successful PV and Med Info operations by leading a 15+ associates’ team along with recruitment, training, performance management, mentorship.Responded to RFP/RFIs and drafted client proposals to develop and generate new business for PV/Med Info services.Contributed to drafting MSA/PV agreements, proofread contracts, collaborated with several Innomar teams to ensure all client deliverables are met.Developed SOPs/WI related to operational processes, created templates/client presentations for QBRs, KPI reviews.Offering solutions and fostering client relationships by continuous engagement and active discussions.Actively collaborate with Innomar Patient Support Programs in client business reviews, presentations, and quality issues.Lead Product and IT development projects required for enhancing database functionality and PV process optimizations.Ensured effectiveness of AE reporting processes, Identifying needs for modification of program database, drug safety database, protocols. Collaborate in identifying training requirement needs, leading refresher adverse event trainingResponsible for daily and on-going client reporting and project communications.Working with senior leaders and program staff to ensure assigned program(s) is audit ready.Working with Quality Assurance and Senior Manager to perform regular Quality ChecksIn collaboration with the Manager, participates in the hiring and training process of new staff.Responsible for the recruitment, training, coaching and performance management.

Toronto, Canada Area

Lead a team of 10-15 associates to meet client deliverables relating to PV activities (E2B PV & Patient Support Programs, Medical Information) for drugs, biologics, biosimilars including seriousness and causality assessments.Performed Health Canada Reconciliation and scientific literature article review using ProQuest, PubMed and Embase.Performed MEDRA coding, PSUR/PBRER, Annual Summary Reports, exposure to signal detection activities.Review client contracts and proposals, RFP/RFIs, PV agreements, SOWs and assist PV Directors with new assignments.Collaborated with IT team in developing/UAT testing for in-house PV database build for electronic submissions to clients.Communicated daily with clients and patient support programs to ensure timely completion of tasks including query resolution, reconciliations, follow ups, CAPAs, metrics, storage, and document archiving.

Toronto, Canada Area

Recognize, triage and report adverse events, adverse drug reactions, product quality complaints of drugs and biologics of leading biopharmaceutical clients as per Health Canada AE Reporting and GVP guidelines. Proficiently handled daily AE & PQC reporting of over 5 patient support programs individually. Updated and entered appropriate safety data into clinical database; ensured data was captured as per departmental SOPs.

Toronto, Ontario

Receive, identify and document all pertinent clinical safety information in compliance with SOPs in clinical databases.Review post-infusion reports , documented AE & PQC in databases for PSPs of over 5000 patients.

Montreal, Canada Area

Conducted Pre-study, interim monitoring and close out site visits for over 20 Phase I & BA/BE clinical trials individually.Ensured compliance with the protocol requirements, study procedures and ICH-GCP guidelines.Perform source data verification, On-site Adverse Events reporting and reconciliation, CRF review & study drug accountability for Phase I & BA/BE clinical trials.Review Regulatory Documents, Informed Consents, REB approvals, Approved CTA documents & Trial Master File.Prepare and issue CAPA, trial initiation and follow up letters to clinical sites.Assist and co-monitor Phase IV clinical trials (In-House Monitoring).

Montreal, Canada Area

Maintain regulatory documentation according to essential guidelines and Trial Master File (TMF) Plans.Participated in monitoring site visits for BA/BE clinical trials.Create and maintain site contacts, feasibility, patient status and regulatory documentation trackers.Conduct remote monitoring, review of CRF's and reconciliation of data queries.Maintain timely and effective communication among team members and site staff via oral/written correspondence.Trained successfully on compliance with applicable Health Canada regulations and guidelines, Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and GCP guidelines.Received hands-on experience on Clinical Trial Monitoring

Montreal, Canada Area

Worked to ensure health, well being and safety of lab research animals ( rats, mice, rabbits, dogs, cats, marmosets, primates including rhesus monkeys)

Montreal, Quebec, Canada

Student in Master's Program in Applied Biotechnology

Montreal, Canada Area

Completed research on “Targeting Cholesterol Recognition Domains in Cancer Cell Growth” Performed Pre-clinical screening of Novel Anti-Breast Cancer Drugs. Synergized Ability of Hits with Marketed Chemotherapeutics (Paclitaxel & Etoposide).Evaluated possible Mechanism of Action of Hits Identified after Screening.

Developed Business Plan and Product Sales Generation.Active on field marketing of Ranbaxy's Derma Division and launching of new division of Ranbaxy- Primalands.

Ms In Applied Biotechnology, Pharma-Biotech

B.Pharm, Pharmaceutical Sciences