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Dr. Sujeetth Kumar S (PMP®, EGMP- IIM Lucknow)
Associate Director - Medical Safety

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Skills
ClinicalClinical DevelopmentClinical ResearchClinical TrialsCTMSDiabetesDrug SafetyDrug Safety & PharmacovigilanceDue DiligenceFDAGCPGood Clinical Practice (GCP)HealthcareHealthcare Information TechnologyHealthcare ManagementHospitalsICH-GCPLifesciencesLife SciencesMedical CodingMedical WritingMedicineOncologyPharmaceutical IndustryPharmacovigilanceProject ManagementPSURRegulatory AffairsSopStrategyTeam ManagementTrainingU.S. Food and Drug Administration (FDA)About me
A competent and profit-focused executive with over 12 years’ of excellence in delivering optimal results in high-growth environments through initiatives that exceed business performance targets in the industry of repute. Adept in performing Safety Strategy and Management Team for complex drugs. Proficient in providing subject matter expertise in the therapeutic area and across multiple products. Well versed with safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. Work with PV team on continuous process improvements in the field of safety surveillance, SOPs, guidance documents, templates, tools, upgrades. In-depth knowledge of US and ICH safety reporting regulations and guidelines Remarkable knowledge to monitor and track Serious Adverse Events, serious and non-serious adverse drug reactions, and other medically related project information. Well exposed to Project Management Life Cycle including project setup & scoping, requirement analysis & technical specifications, effort & cost estimation, risk management, planning, monitoring and tracking, reporting & communication, process management & compliance, change management, resource optimization.
Education

Physis Learning Academy
2019 - 2019CERTIFICATE PROGRAM IN DRUG REGULATORY AFFAIRS REGULATORY AFFAIRS ATopics covered1. Introduction to Drug Regulatory Affairs.2. Regulatory Authorities.3. Regulatory requirements in Pharmaceutical.4. Medical Device Regulation.5. Applicable ICH Guidelines in Drug Regulatory Affairs.

Indian Institute of Management, Lucknow
2014 - 2015Executive General Management Program Business Administration and Management, GeneralActivities and Societies: Business Economics, Quantitative Techniques for decision making, Organization Behavior, Management Accounting, Strategic Management, Operations Management, Marketing Management, Supply Chain Management, Corporate Finance, Human Resource Management, Business Communication, International Business Environment Executive General Management Program in IIM-LucknowBatch : EGMP-06 - IIM-LBatch Code : EGMPX06

Rajiv Gandhi University of Health Sciences
2002 - 2008Bachelor of Medicine, Bachelor of Surgery - MBBS Medicine
Experience

IQVIA
Feb 2021 - nowAssociate Director - Medical SafetyManage Pharmacovigilance physician staff in accordance with organization’s policies and applicable regulations.Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.• Develop and maintain a high quality and efficient adverse event medical review and evaluation structure for investigational and marketed products, while adhering to governing SOPs, work instructions and ICF-I guidelines and regulatory guidelines.• Assure timely movement of medical review work through the process steps in accordance to governing SOPs, work instructions, and client expectations.• Responsible for development, setting up and expansion of team of physicians as required.• Responsible for overall quality management of the group and implement quality improvement initiatives as appropriate.• Assist with establishment and maintenance of relevant SOPs and work instructions to support efficient processes and procedures. Participate in continuous improvement of all departmental processes and procedures.• Participate in business development, marketing and sales activities as appropriate.• Instruct and lead direct reports in efficient management of project budget, agreed contracts (SLA5) and monitor project time changes within the functional groups.• Establish and/or maintain appropriate forecasting tools for reporting forecasted utilization.• Participate and lead in the Business continuity plan as required. Show less
Licenses & Certifications

Project Management Professional (PMP)
Project Management InstituteApr 2021
Honors & Awards
- Awarded to Dr. Sujeetth Kumar S (PMP®, EGMP- IIM Lucknow)GCP Certification Barnett International Apr 2015 Good Clinical Practice for Clinical Trials: Fundamentals (Barnett International) Completed on: 13 April 2015
Languages
- enEnglish
- hiHindi
- kaKannada
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