Karthikeyan S
Drug Safety Scientist, Quality reviewer and certified process trainer
Chennai,Tamil Nādu
Summary
Dedicated and quality-driven Drug Safety professional with over 20 years of cross-functional experience spanning pharmacovigilance, medical coding, clinical data management, and regulatory safety compliance. Adept at ensuring patient safety by managing adverse event reporting, analyzing risk-benefit profiles, and maintaining high standards in global regulatory requirements. Proven track record of working across therapeutic areas and international settings, with a strong ability to lead safety operations, support audits, and collaborate effectively with cross- functional stakeholders. Seeking to contribute clinical insight, operational excellence, and a deep commitment to regulatory integrity in a dynamic drug safety environment. Communicative Scientist proficient in adverse event, product complaint and medical information. Talented individual educated in safety procedures, processes and regulations. Pursuing role and leveraging exceptional technical knowledge to better satisfy customer needs. Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.
Overview
22
22
years of professional experience
Work History
Drug Safety Scientist (Medical Information Call Centre)
Qinecsa Solutions
04.2024 - 06.2025
- Manage Intake and Documentation of Safety Information- Efficiently handle safety-related inquiries and reports received via phone, email, fax, or mail, ensuring accurate entry, tracking, and creation of corresponding annexures in compliance with regulatory and internal guidelines.
- Ensure Compliance with Pharmacovigilance Protocols - Adhere strictly to global regulatory standards and company procedures for recording and reporting adverse events (AEs), serious adverse events (SAEs), product complaints, and medical inquiries from all sources.
- Perform Case Processing and Data Quality Checks - Accurately document and process Individual Case Safety Reports (ICSRs), including literature and postmarketing surveillance cases, ensuring completeness, clarity, and compliance with Good Documentation Practices (GDP).
- Execute Medical Follow-ups and Communication - Initiate and manage follow-up communications with reporters or healthcare professionals to obtain missing or clarifying information, maintaining professional client interaction and high-quality documentation.
- Utilize Medical Resources for Information Handling - Respond to medical information queries using approved product labeling, standard FAQs, and therapeutic knowledge to ensure consistent and scientifically accurate responses.
- Conduct Risk Evaluation and Signal Detection - Support risk-benefit assessments by identifying patterns and safety signals through analysis of adverse event data, contributing to early detection and mitigation of potential safety issues.
- Contribute to Literature Surveillance and Case Identification - Perform systematic literature searches to identify and evaluate published safety data relevant to company products, incorporating findings into safety evaluations and reports.
- Support Clinical Trial and Post-Marketing Safety Monitoring - Monitor ongoing clinical studies for safety events and ensure prompt and compliant reporting in alignment with global regulatory timelines and company policies.
- Assist in Risk Management and Regulatory Reporting - Aid in the development of risk management strategies, including preparation and submission of safety reports such as PSURs, DSURs, and other regulatory documents to authorities and stakeholders.
- Facilitate Training and Cross-Functional Collaboration - Contribute to team learning initiatives by sharing pharmacovigilance best practices, promoting awareness of regulatory updates, and fostering collaboration across safety, regulatory, and medical affairs functions.
Senior Drug Safety Associate
Bioclinica India Pvt Ltd
03.2018 - 03.2024
- Improved regulatory compliance by ensuring timely submission of periodic safety reports to health authorities.
- Streamlined adverse event case management, leading to improved efficiency and accuracy in data analysis.
- Championed best practices in pharmacovigilance, establishing a culture of continuous improvement within the drug safety department.
- Managed complex projects, coordinating tasks among various teams to achieve successful outcomes within tight deadlines.
- Provided critical support during product recalls, coordinating efforts across multiple departments to ensure swift resolution of issues at hand.
- Maintained awareness of performance metrics to remain within established limits.
- Trained and mentored new staff to achieve efficiency and maintain daily operational consistency.
Drug Safety Associate
Syknowledge Pvt Ltd
03.2016 - 03.2018
- Improved patient safety by accurately reviewing and processing adverse event reports.
Medical Officer
Alankit Assignments Ltd.
12.2015 - 02.2016
- Advising on Medi-claim insurance cases.
- Interpreted diagnostic test results for deviations from normal.
- Reviewed complex cases alongside colleagues during peer consultations to develop consensus on appropriate courses of action for challenging scenarios.
- Improved patient outcomes by implementing evidence-based medical practices and protocols.
Proprietor & Principal Dentist
Dentsopt Dental Clinic
07.2015 - 02.2016
- Overseeing clinical operations.
- Managed day-to-day business operations.
- Oversaw daily operations, ensuring all tasks were completed accurately and efficiently by team members.
- Trained and motivated employees to perform daily business functions.
- Increased customer satisfaction by implementing efficient business processes and providing exceptional service.
Associate Dentist
Madhar Dental Care
11.2014 - 06.2015
- Managing general dentistry responsibilities.
Medical Coding Specialist
Theorem Clinical Research
01.2013 - 10.2014
- Coding CRF data using MedDRA & WHO-DD.
ICON Clinical Research
Chennai
08.2009 - 07.2013
- Performing MedDRA, WHO-DD, and ATC coding across therapeutic areas.
Founder and Principal Dentist
Dental Boutique Clinic
05.2007 - 03.2010
- Managing end-to-end patient care and practice operations.
- Implemented efficient operational processes to optimize productivity and resource allocation.
- Guided team members through periods of change by providing clear communication on expectations and objectives moving forward.
- Built a positive organizational culture that fostered creativity, innovation, and employee engagement.
- Created and monitored promotional approaches to increase sales and profit levels.
- Introduced advanced technology solutions into daily operations which led to increased productivity levels throughout the company.
Clinical Intern
Orthodontic Clinic
Chennai
01.2003 - 01.2005
- Gaining hands-on experience in orthodontics and general dentistry.
- Developed patient care plans in collaboration with healthcare teams, focusing on individual needs and promoting recovery.
- Streamlined documentation process for patient records, enhancing accuracy and accessibility of vital health information.
- Improved patient outcomes by meticulously recording and tracking their vital signs and symptoms over course of clinical internships.
Education
High School Diploma -
PS Higher Scondary School
Chennai04.1998
Skills
Drug safety, pharmacovigilance, Clinical practice, WHO DD and MedDRA coder, Clinical Data Management
Project management
Peer reviews
Safety processes and procedures
Critical thinking
Problem-solving abilities
Teamwork and collaboration
Problem-solving
Time management
Excellent communication
Interpersonal skills
Effective communication
Adaptability
Strong work ethic
Timeline
Drug Safety Scientist (Medical Information Call Centre)
Qinecsa Solutions
04.2024 - 06.2025
Senior Drug Safety Associate
Bioclinica India Pvt Ltd
03.2018 - 03.2024
Drug Safety Associate
Syknowledge Pvt Ltd
03.2016 - 03.2018
Medical Officer
Alankit Assignments Ltd.
12.2015 - 02.2016
Proprietor & Principal Dentist
Dentsopt Dental Clinic
07.2015 - 02.2016
Associate Dentist
Madhar Dental Care
11.2014 - 06.2015
Medical Coding Specialist
Theorem Clinical Research
01.2013 - 10.2014
ICON Clinical Research
08.2009 - 07.2013
Founder and Principal Dentist
Dental Boutique Clinic
05.2007 - 03.2010
Clinical Intern
Orthodontic Clinic
01.2003 - 01.2005
High School Diploma -
PS Higher Scondary School