SUSHMA MAKAM
CA
Summary
- Have around3 years of experience in pharmacovigilance field as a OPERATIONS SPECIALIST-I at IQVIA.
- I have worked on various products like oncology, central nervous system, consumer, anti-infective, urology, biologics.
- Skilled in ICH-GCP communication, Good clinical practice(GCP), Good manufacturing practices(GMP), ARGUS data base, case processing.
- Experience in handling individual case safety report(ICSR).
- I have handled all types of cases and case reports such as spontaneous, study, clinical trials, literature articles, E2b documents, NSNI case reports, PQC reports.
- Able to process all types of reports received from different countries across the world.
- Able to review adverse events and serious adverse events in clinical trials.
- Ensure timely and quality reports to be reported to the regulatory authority.
- Recording and reporting adverse reaction reported from health care professional and consumers.
- Ability in data entry, labeling assessment, MEDRA and WHODD coding.
- Good understanding of clinical trial concepts and worked on clinical trial cases.
- Excellent in verbal/oral, and telephone etiquette and communication.
- Known for providing correct and complete information.
Offering solid foundation in scientific principles and passion for ensuring patient safety, ready to learn and develop in pharmacovigilance environment. Brings ability to quickly understand and apply regulatory guidelines and safety protocols. Ready to use and develop analytical thinking and meticulous attention to detail in [Desired Position] role.
Overview
3
3
years of professional experience
Work History
Pharmacovigilance Specialist
IQVIA
09.2020 - 03.2024
- Assisted in the preparation of periodic safety update reports, ensuring timely submission to regulatory authorities.
- Responded to requests from regulatory agencies and notified to share information.
- Managed multiple projects simultaneously while meeting tight deadlines and maintaining high-quality work standards in a fast-paced environment.
Education
Doctor of pharmacy (pharm D) -
JNTU university
01.2020
Intermediate - undefined
Sri Chaitanya Junior College
01.2013
SSC - undefined
Pragathi Vidya Niketan school
01.2011
Skills
- Argus database
- Pharmacovigilance
- MedDRA coding
- ICH-GCP guidelines
- AE and SAE reporting timelines worldwide
- Good at MS Office(PowerPoint, excel, word)
- Case processing
- Adverse event reporting
Responsibilities:
Responsible for prioritization of cases in global safety database. Good medical evaluation skills, and well versed with database. Responsible of handling cases from log to case processing by coding appropriate terms in MedDRA. Responsible for quality reviewing, evaluation and reporting the cases. Assuring medically cohesive narrative with completeness and accuracy. Follow up on reconciliation discrepancies. Closure and deletion of cases. Follow departmental AE work flow procedures. Participating in query resolution for the new associates. Identifying clinically relevant information missing from the case report. Identification of duplicate cases, complete and accurate data entry of ICSR. Additional team responsibilities of productivity, age and age group analysis, SUSAR checking. Skilled in Microsoft office.
STRENGTHS:
Maintaining good interpersonal relationships. Willingness to work and ability to adapt to the situation. Ability to work in a team efficiently.
Training
- I have done my internship in kamineni medical hospital, Hyderabad for1 year. Specialization done2months in oncology ward,2months in general surgery ward,2months in general medicine ward,2months in orthopedic ward,2months in neurology ward,2months in psychiatry ward.
- I have undergone certification in Clinical research, Pharmacovigilance, Clinical data management, Regulatory affairs and medical writing.
Disclaimer
I hereby declare that the above written particulars are true to the best of my Knowledge. (MAKAM SUSHMA)
bronze
I have got bronze award in my past work experience for my productivity, supporting the team, quick learner.
Timeline
Pharmacovigilance Specialist
IQVIA
09.2020 - 03.2024
Intermediate - undefined
Sri Chaitanya Junior College
SSC - undefined
Pragathi Vidya Niketan school
Doctor of pharmacy (pharm D) -
JNTU university
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