KARANVIR SINGH KANWAR

• Partnered with project team members to identify and quickly address problems.
• Mentored junior team members, fostering professional growth and increasing overall team efficiency.
• Reduced project completion timeframes through strategic resource allocation and efficient task delegation.
• Implemented best practices in documentation management systems that improved efficiency, accessibility, and security of project-related information.
• Collaborated with cross-functional teams to ensure seamless integration of various project components.
• Managed change requests effectively by evaluating impacts on scope, timeline, or budget before approving them in a timely manner to avoid delays or escalations in costs.
• Produced quality standards, checklists, report templates, and processes.
• Increased stakeholder engagement by conducting regular status updates and addressing concerns proactively.
• Optimized resource utilization by accurately forecasting project needs and allocating resources accordingly throughout the project lifecycle.
• Enhanced stakeholder satisfaction by consistently delivering high-quality projects within budget and on schedule.
• Contributed to the development of company-wide project management strategies, resulting in more streamlined processes and increased productivity.
• Improved overall team performance by conducting regular performance evaluations and providing constructive feedback to facilitate professional growth.
• Conducted thorough risk assessments to identify potential issues early on, allowing for proactive mitigation strategies to be implemented.
• Maintained open communication by presenting regular updates on project status to stakeholders.

• Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
• Planned, designed, and scheduled phases for large projects.
• Identified plans and resources required to meet project goals and objectives.
• Monitored project performance to identify areas of improvement and make adjustments.
• Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
• Established effective communication among team members for enhanced collaboration and successful project completion.
• Coordinated with cross-functional teams to resolve project issues and mitigate risks.
• Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
• Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
• Coordinated cross-functional teams and resolved conflicts, maintaining a positive work environment throughout the project lifecycle.
• Prepared detailed reports on project status for stakeholders, ensuring transparency and alignment with objectives.
• Provided detailed project status updates to stakeholders and executive management.
• Collaborated closely with senior management to align project objectives with strategic company initiatives, ensuring that efforts contributed to overall business growth.
• Developed and implemented strategic project plans to meet business objectives.
• Streamlined project processes by implementing Agile methodologies, resulting in increased efficiency and reduced costs.
• Facilitated workshops to collect project requirements and user feedback.

• Utilized exceptional writing, editing, and proofreading skills to produce engaging and error-free content.
• Followed company policies and editorial guidelines to craft thorough, well-written content.
• Wrote compelling, succinct, clear news scripts under tight deadlines.
• Conducted thorough research on diverse topics, producing well-informed pieces that resonated with readers.
• Organized material to research and complete writing tasks.
• Repurposed and optimized existing content for use in different mediums.
• Provided writing support for various projects and departments.
• Mentored junior writers in developing strong writing skills and adhering to company style guidelines.
• Incorporated review comments and corrections into existing documentation.

• Mentored junior medical writers in best practices and industry standards, fostering a collaborative work environment that enhanced team productivity.
• Developed training materials for medical writers to enhance their understanding of industry guidelines and best practices, resulting in improved document quality.
• Facilitated productive relationships between medical writers and other functional groups by serving as a key point of contact for project-related inquiries.
• Optimized the medical writing process by implementing new software tools and technologies, increasing efficiency and reducing errors.
• Streamlined regulatory submission processes by efficiently managing multiple medical writing projects simultaneously.
• Implemented process improvements that led to increased efficiency in medical writing workflows, resulting in timely delivery of quality documentation.
• Negotiated on behalf of medical writing to align resources, timelines and expectations.

• Enhanced drug safety by analyzing adverse event reports and identifying potential risks.
• Promoted a culture of safety within the organization by championing pharmacovigilance best practices and fostering an environment of open communication and collaboration.
• Managed multiple projects simultaneously while meeting tight deadlines and maintaining high-quality work standards in a fast-paced environment.
• Conducted comprehensive literature reviews to stay current on emerging trends in pharmacovigilance practices.
• Evaluated safety profiles, wrote signal detection reports and monitored document filing and archiving.
• Coordinated closely with medical affairs teams to ensure accurate reporting of product-related adverse events from post-marketing studies and spontaneous reports.
• Maintained strong relationships with external partners such as contract research organizations, fostering effective collaboration on pharmacovigilance projects.
• Read scientific literature and bibliographic sources.
• Exceeded inspection readiness targets through meticulous record-keeping and adherence to standard operating procedures.
• Trained staff and updated training documents to meet regulations and standards.
• Initiated process improvement initiatives that resulted in reduced case processing times without compromising data quality or integrity.
• Provided training for new pharmacovigilance team members, fostering a culture of continuous learning and improvement.
• Provided subject matter expertise to support the development of training materials, standard operating procedures, and work instructions within the department.
• Improved regulatory compliance with thorough documentation of adverse events and follow-up actions.
• Collaborated with cross-functional teams to develop comprehensive safety surveillance strategies for clinical trials.
• Authored and managed regular safety update reports.
• Supported inspections, visits and audits as well as CAPAs management.
• Contributed to the development of risk management plans for new pharmaceutical products.
• Reviewed, compiled and analyzed data for safety database management.
• Assisted in the preparation of periodic safety update reports, ensuring timely submission to regulatory authorities.
• Monitored deliverables for quality and adherence to regulatory reporting timelines.
• Reported problems and concerns to management.

• Enhanced drug safety by analyzing adverse event reports and identifying potential risks.
• Read scientific literature and bibliographic sources.
• Authored and managed regular safety update reports.
• Assisted in the preparation of periodic safety update reports, ensuring timely submission to regulatory authorities.
• Evaluated safety profiles, wrote signal detection reports and monitored document filing and archiving.
• Trained staff and updated training documents to meet regulations and standards.
• Supported signal detection activities by conducting ongoing monitoring and analysis of safety data from various sources.
• Reviewed, compiled and analyzed data for safety database management.

• Initiated process improvement initiatives that resulted in reduced case processing times without compromising data quality or integrity.
• Evaluated incoming case reports for completeness, accuracy, and consistency before entering them into the global safety database.
• Oversaw adverse events case reporting and conducted follow-up.
• Developed innovative solutions for complex case processing challenges, enhancing overall efficiency within the department.
• Conducted case reconciliation with internal departments, distributors, affiliates and business partners.
• Supported signal detection activities by conducting ongoing monitoring and analysis of safety data from various sources.
• Collaborated with cross-functional teams to develop comprehensive safety surveillance strategies for clinical trials.
• Reviewed, compiled and analyzed data for safety database management.
• Documented and executed detailed test plans and test cases and summarized and logged audit findings for reporting purposes.
• Enhanced drug safety by analyzing adverse event reports and identifying potential risks.
• Promoted a culture of safety within the organization by championing pharmacovigilance best practices and fostering an environment of open communication and collaboration.
• Conducted comprehensive literature reviews to stay current on emerging trends in pharmacovigilance practices.
• Provided training for new pharmacovigilance team members, fostering a culture of continuous learning and improvement.
• Assisted with preparation and implementation of pharmacovigilance agreements and contracts.
• Streamlined pharmacovigilance processes by implementing new software and data analysis tools.