Prashanth Vardhan
Pune
Summary
Adept at steering high-stakes projects to success, I leveraged analytical thinking and Argus software proficiency at Fortrea Scientific Services to enhance pharmacovigilance systems. My leadership, underscored by a knack for team building and performance management, significantly improved operational efficiency, showcasing a commitment to excellence and innovation in challenging environments.
Overview
17
17
years of professional experience
Work History
Senior Manager
Fortrea Scientific Services Pvt ltd
Pune
11.2020 - Current
- Participated in internal meetings concerning pharmacovigilance topics and presented updates on safety issues related to products under surveillance.
- Assessed the impact of new regulations on existing pharmacovigilance systems.
- Mediated conflicts between employees and facilitated effective resolutions to disputes.
- Coordinated with internal departments to ensure successful execution of projects according to timeline and budget constraints.
- Coordinated with marketing to develop branding and promotional strategies.
- Monitored compliance with industry regulations and company policies to mitigate risk.
- Provided strategic direction to departmental heads regarding resource allocation decisions.
- Produced thorough, accurate and timely reports of project activities.
- Collaborated with external vendors to negotiate contracts that met company requirements while minimizing costs.
- Interviewed prospective employees and provided input to HR on hiring decisions.
- Established effective communication channels between different departments within the organization.
- Implemented quality control measures to uphold company standards.
- Reviewed completed work to verify consistency, quality, and conformance.
- Analyzed business performance data and forecasted business results for upper management.
- Organized team activities to build camaraderie and foster pleasant workplace culture.
- Negotiated contracts with vendors to secure favorable terms and pricing.
Senior Manager
IQVIA
Bengaluru
05.2020 - 10.2020
- Organized team activities to build camaraderie and foster pleasant workplace culture.
- Negotiated contracts with vendors to secure favorable terms and pricing.
- Conducted performance reviews and provided feedback to direct reports for career development.
- Coordinated with IT department to implement new technologies and systems enhancements.
- Held regular one-on-one meetings with employees to review performance and priorities and provide feedback.
- Implemented process improvements to increase operational efficiency and reduce costs.
- Implemented customer service excellence standards to enhance client satisfaction and loyalty.
- Oversaw talent acquisition, training, and development programs to build high-performing teams.
- Established and maintained relationships with key stakeholders to support business objectives.
- Regularly evaluated customer satisfaction levels by surveying customer base and analyzing results.
- Leadership role in planning annual budgets for each department based on forecasted sales volumes.
- Analyzed competitive landscape to adjust strategies and maintain competitive advantage.
- Assigned work and monitored performance of project personnel.
- Delegated work to staff, setting priorities and goals.
- Directed market research and analysis to identify trends and inform business decisions.
Team Manager
Cognizant
Hyderabad
10.2016 - 05.2020
- Encouraged continuous learning and professional development within the team, facilitating external and internal training opportunities.
- Implemented strategic team objectives aligned with company goals, increasing productivity.
- Resolved customer inquiries and complaints requiring management-level escalation.
- Interviewed prospective employees and provided input to HR on hiring decisions.
- Collaborated with other managers across the organization in order to identify best practices that could be implemented at all levels.
- Held regular one-on-one meetings with employees to review performance and priorities and provide feedback.
- Led regular team meetings to communicate current business trends and relevant updates.
Team Manager
Sciformix technologies Pvt ltd
Pune
01.2015 - 10.2016
- Reviewed candidate resumes and scheduled and interviewed potential new hires.
- Negotiated contracts with vendors to secure favorable terms and pricing.
- Fostered an inclusive team culture, promoting diversity and encouraging innovative ideas.
- Conducted regular performance evaluations, providing constructive feedback and personal development plans.
- Collaborated with other managers across the organization in order to identify best practices that could be implemented at all levels.
- Analyzed business performance data to identify areas of strength and improve areas of weakness.
Quality Lead
Sciformix technologies Pvt ltd
Pune
01.2014 - 01.2015
- Developed methods for boosting operational effectiveness alongside robust safety measures.
- Established and executed customer satisfaction program.
- Administered training programs on diverse standards while ensuring continuous compliance.
- Drafted detailed reports on inspection results and presented findings to management team.
- Reviewed documents such as SOPs, BOMs, drawings and specifications before product launch.
- Coordinated project evaluations, gap analyses, department and project audits and quality improvement action plans.
- Analyzed global drug utilization data to detect any unexpected patterns that may indicate a safety issue.
- Interpreted complex scientific data from clinical trials in order to evaluate the safety profile of pharmaceuticals.
- Maintained a database of adverse events received from various sources including spontaneous reporting systems.
- Received and inspected raw materials.
Quality Assurance Coordinator
Sciformix technologies Pvt ltd
Pune
01.2013 - 01.2014
- Maintained policy, procedures, work instructions, and projects for quality and continuous improvement agendas.
- Collected and analyzed production samples to evaluate quality.
- Performed follow-up evaluations to determine efficacy of previously implemented corrective measures, recommending subsequent actions based on findings.
- Identified opportunities for cost savings through improved efficiency within the Quality Assurance process.
- Developed processes and procedures for pharmacovigilance activities in accordance with applicable regulations.
- Participated in technical trainings and workshops to improve skills set and boost overall knowledge.
- Monitored and upheld safe operating procedures and clean area mandates to meet regulatory requirements.
- Maintained database integrity through accurate data entry into the Pharmacovigilance System Database.
Senior Safety Data Analyst
Sciformix technologies Pvt Ltd
Pune
10.2012 - 01.2013
- Prepared safety sections of regulatory documents such as INDs, CTDs, IBs, PBRERs, PSURs, DSURs, PADERs.
- Developed and maintained tracking systems to monitor safety signals from individual case safety reports and literature sources.
- Provided guidance on local requirements for submission of ICSRs to health authorities or ethics committees when needed.
- Contributed to development of process improvements within the department aimed at increasing efficiency and effectiveness.
- Identified and recommended improvements in routine analytical methods and processes.
- Managed laboratory inventory and ensured compliance with safety regulations.
- Investigated complex cases requiring detailed analysis involving multiple factors such as concomitant medications or other confounding variables.
- Analyzed aggregate data from clinical trials to assess the frequency of adverse events associated with investigational drugs.
- Obtained and reviewed data and information from scientific publications and literature.
- Participated in development of SOPs related to pharmacovigilance activities in accordance with global guidelines.
Safety Data Analyst
Icon
Chennai
05.2011 - 10.2011
- Collaborated closely with healthcare professionals to monitor and assess quality and effectiveness of drugs or drug regimens.
- Collaborated with internal teams to ensure timely completion of safety data collection activities.
- Assessed the impact of new regulations on existing pharmacovigilance systems.
- Assisted in the preparation of training materials related to pharmacovigilance best practices.
- Analyzed patient medical histories, laboratory results, and other relevant information to assess potential risks associated with medication use.
- Outlined remediation plans to standardize results to meet compliance regulations.
Safety Processing Expert
Novartis Healthcare Pvt ltd
Hyderabad
06.2008 - 04.2011
- Participated in internal meetings concerning pharmacovigilance topics and presented updates on safety issues related to products under surveillance.
- Conducted proactive data mining activities to identify potential safety signals in large datasets.
- Provided support on signal management activities such as risk assessment, root cause analysis, development of mitigation strategies.
- Received and inspected raw materials.
- Evaluated individual cases for appropriate follow-up action including Medical Information inquiries, Field Safety Corrective Actions, and serious adverse event reporting to regulatory authorities worldwide.
- Participated in technical trainings and workshops to improve skills set and boost overall knowledge.
- Performed quality control inspections at customer sites to determine alignment with safety regulations.
- Outlined remediation plans to standardize results to meet compliance regulations.
- Provided guidance on pharmacovigilance requirements to global affiliates.
Education
Diploma in Pharmacovigilance - Pharmacology
Medwin Institute of Medical Sciences
Hyderabad05-2007
Bachelor of Science - Pharmacy
Shadan College of Pharmacy
Hyderabad04-2005
Skills
- Reporting Accuracy Oversight
- Performance Management Expertise
- Equipment decommissioning
- Corporate communications
- Logistics operations management
- Organizational development
- Argus software
- ARGUS enterprise
- Argus software proficiency
- Troubleshooting
- Team building
- Computer skills
- MS office
- Analytical thinking
Affiliations
- Always ensure that the team meets SLA
- Quality Driven
- Ensure that the employees are happy
- Make sure that the customer never complain
Timeline
Senior Manager
Fortrea Scientific Services Pvt ltd
11.2020 - Current
Senior Manager
IQVIA
05.2020 - 10.2020
Team Manager
Cognizant
10.2016 - 05.2020
Team Manager
Sciformix technologies Pvt ltd
01.2015 - 10.2016
Quality Lead
Sciformix technologies Pvt ltd
01.2014 - 01.2015
Quality Assurance Coordinator
Sciformix technologies Pvt ltd
01.2013 - 01.2014
Senior Safety Data Analyst
Sciformix technologies Pvt Ltd
10.2012 - 01.2013
Safety Data Analyst
Icon
05.2011 - 10.2011
Safety Processing Expert
Novartis Healthcare Pvt ltd
06.2008 - 04.2011
Diploma in Pharmacovigilance - Pharmacology
Medwin Institute of Medical Sciences
Bachelor of Science - Pharmacy
Shadan College of Pharmacy
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