Drug Safety Data Entry
Resume:
*************@*****.***
Dedicated and detail-oriented Drug Safety Associate with over almost five years of experience in pharmacovigilance and drug safety monitoring. Adept at managing adverse event reports, conducting thorough case evaluations, and ensuring compliance with regulatory requirements. Possesses a strong background in data analysis, risk assessment, and safety signal detection. Proven ability to work collaboratively in cross-functional teams to support clinical development and post-marketing surveillance. Demonstrates excellent communication skills, both written and verbal, and a commitment to maintaining the highest standards of patient safety. QUALIFICATIONS
DEGREE INSTITUTE/UNIVERSITY YEAR SPECIALIZATION
Bachelor of Dental
Surgery (B.D.S)
Adesh University 2018 DENTAL SCIENCE
12TH South Delhi Public School,
New Delhi
2012 PCB
10TH South Delhi Public School,
New Delhi
2010 SCIENCES
SUMMARY OF EXPERIENCE
• Drug Safety Associate II, Parexel International Chandigarh, India (March 2022 – 2024)
• Drug Safety Associate I, Parexel International Services, Chandigarh, India (July 2020 - Mar 2022)
• Drug Safety Associate, Parexel International Chandigarh, India (Sep 2019 – July 2020)
• More than 3 + years of experience in pharmacovigilance including triage, initiation, writing company comments and medical regulatory assessment of Individual Case Safety Reports (ICSRs).
• Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities. Kartik Naveen Raina Drug Safety Associate-II
Bachelor of Dental Surgery (BDS)
PROFESSIONAL SUMMARY
• Expertise in managing Individual Case Safety Reports (ICSRs) of various case types
(spontaneous, clinical studies, solicited programs and literature cases) at book in, Registration/initiation of ICSRs into the safety database.
• Conducting duplicate searches prior to registration and identifying potential duplicates.
• Managing amendments for duplicate cases appropriately, data entry of ICSRs in the safety database.
• Familiar with international drug safety regulations (including ICH guidelines on safety and efficacy, US FDA guidelines, CIOMS, New EU PV legislation).
• Maintaining good working knowledge of reference safety information document, data entry conventions and guidelines, client’s procedures and international drug safety regulations.
• Two years as an Associate Dentist in Whitey’s dental clinic. SKILLS
• Excellent knowledge of medical terminology.
• Strong written and communication skills.
• MS Office – Excel / Power point / Word and google forms
• Microsoft Windows 7 /8 /10
LANGUAGE SKILLS
• Fluency in English, Hindi, Punjabi and Kashmiri. WORK-RELATED TRAINING
• Experienced in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies and solicited programs) which includes
• Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities
• Registration of ICSRs into the safety database.
• Managing duplicate couples/cases appropriately.
• Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents (such as SPC, CDS, IB etc.)
• Writing case summaries, assessing causalities if required and writing company comment if required.
• Data validation i.e., crosses checking against source documentation.
• Good knowledge in EUDRAVIGILANCE AND ELECTRONIC INTAKE OVERSIGHT PROCESS and experienced in Electronic (E2B) Intake Cases imported in Global PV Database.
• Experienced in understanding the client business requirements and ability to attain a vision from project level prospective.
• Experienced in Deletion Merger Activity when case found duplicates in the database.
• Experienced in handling queries within the team received from client partners.
• Trained in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”.
• Experienced in maintaining a good working knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, client procedures and international drug safety regulations including - ICH guidelines on safety and efficacy - New EU PV legislation - FDA guidelines
• Awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
• Worked on Artemis tool for duplicate queue assessment.
• Experienced in writing adverse drug reports.
KEY STRENGTHS
• Good at connecting to people
• Communicative skills
• Organized
• Interpersonal skills
• Self-disciplined
• Team management
• Hard working
• Good observer
• Positive attitude
DECLARATION
I hereby declare that the information given above is true and no fact pertaining to my academic qualification or experience has been concealed.
Kartik Naveen Raina
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