DEVA PRIYA
Chennai,TN
Summary
Accomplished Pharmacovigilance Associate with over 3.6 years of experience in the Pharmacovigilance sector, notably with Icon plc. Demonstrated expertise in drug safety guidelines and exceptional communication skills, ensuring accurate adverse event documentation and fostering strong client relationships. Dedicated expert with focus on maintaining drug safety by preparing and reviewing data and reports. Meticulous when authoring professional documents and reviewing scientific literature.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Pharmacovigilance Associate
Icon Plc
2021.04 - Current
- Gastric and colorectal cancer (Metastatic)
- Review and process safety events (pre-marketing, post-marketing, medical device, and drug) and/or other medically related information per assigned tasks and project specific procedures. Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products
- Generates data listings from the safety database and assumes responsibility for accuracy of the data
- Complete adverse event follow-up in writing and/or by phone based on requirements for each Client
- Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files Perform safety review of clinical and diagnostic data as part of case processing
- Responsible for effective and efficient development of the Safety
- Management Plan, including development of specific processes to assure consistency within the project
- Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER
- Support Qualified Person for Pharmacovigilance as required. Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues
- Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate
- Assist with identifying out of scope activities in conjunction with the Pharmacovigilance Project lead (as applicable)
- Attend project team and Sponsor meetings and teleconferences as required including presentation of the safety process at kick-off and investigator meetings
- Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks. Supports interim data analysis for DMC reviews
- Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process
- Supports creation of the SAE/AE reconciliation plan and supports
- SAE reconciliation in accordance with this plan and other project specific guidelines
- Supports Safety Scientist in signal detection and risk management activities
- Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately
- Proposes solutions for procedural and technical issues
- Supports audits and inspections as required for the assigned projects
- Perform other activities as identified and requested by management including but not limited to: Respond and process medical information inquiries including inquiries related to adverse events and product complaints for Clients’ product(s), as per their agreement with ICON.
Drug Safety Associate E/L
Icon Plc
2021.04 - 2023.09
- Literature review of articles and signal detection
- Responsible for performing processing for all types of safety events (including safety database entry and narrative preparation), and other medically related project information under mentorship of a Drug Safety Associate or above, ensuring all ICON, Sponsor, and regulatory timelines are met for the processing and reporting of safety information and assisting in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.
Education
Doctor of Pharmacy - Pharmacy
Jaya College of Pharmacy
Chennai, India12.2020
Internship - General Medicines, Surgery, Pediatrics, OBG
Hindu Mission Hospital
Chennai, India12.2019
Clerkship - General Medicines, Surgery, Pediatrics, OBG
THIRUVALLUR GOVERNMENT HOSPITAL
Chennai, India06.2017
Skills
- Strong knowledge in the field of Pharmacovigilance with experience in supporting oncology products
- Experience in Pharmacovigilance for 3.6 years
- Strong background in FDA drug safety guidelines
- Extensive training in corporate integrity and proper interactions with healthcare professionals
- Adverse event reporting
- Medical terminology knowledge
- Signal detection proficiency
- Scientific literature review
- Drug safety expertise
- Case processing abilities
- Data Entry
- Quality Review
- Narrative writing
Certification
Registered Pharmacist at Pharmacy Council of India
Presentations And Publications
- Poster presentation entitled “FORMULATION AND EVALUATION OF ERLOTINIB LOADED PLGA NANOPARTICLES: at the1st international drug delivery congress 2017 (idc-2017) organized by RVS college of pharmaceutical sciences and RVS College of Pharmaceutical Sciences and RVS Padmavathi Ammal College of Pharmacy, Sulur, Coimbatore from 20th-21st January 2017
- Deva Priya.S.A, Dr.Pearlsy Grace Rajan, Melina.I.Sahay, Dr.Damal Kandadai Sriram, dr.Melvin George. Budd Chiari Syndrome- An Overview. IOSR Journal of Dental and Medical Sciences (IOSR-JDMS).Volume 19, Issue 4 Ser.1 (April. 2020), PP 57-61
- Kavitha.S, Sabishruthi.S, Deva Priya.S.A, Pavani.S, Sreesandya.G, “Epilepsy Induced Anxiety Disorders in a Tertiary care Hospital – A Case Study”. American Journal of PharmTech Research (AJPTR), 2020, 10(01): 25-30
- Asha k rajan, Vedha Pal Jeyamani, jaganathan.b, Deva Priya.S.A, Franklin Jose.J. Impact of patient counseling and improvement on erythrodermic psoriasis case study. Journal of medical science and clinical research, 2017; 05(12): 31707-10
- Bhuvaneshwari P, Punitha S, Devapriya S.A. Chronic Kidney Disease Federated With Diabetes Mellitus, Hypertension, Tramadol Hydrochloride – A Case Series, European Journal Of Pharmaceutical And Medical Research,2021;8(1).
Certifications
- Advanced cardiac life support (ACLS) Certification & recertification course from
National Health Care Provider Solutions (NHCPS)-Nov 2020 - Stasistical reasoning and alogirthms in pharmacovigilance &Signal detection and
casualty assessment from Uppsala Monitoring Centre Nov 2020 - Good Clincal Practice (GCP) Certification from the NIDA Clinical Trials network
Dec 2019.
Skills
PowerPoint, Excel, Argus, Arisg, LSMV(Current)
Timeline
Pharmacovigilance Associate
Icon Plc
2021.04 - Current
Drug Safety Associate E/L
Icon Plc
2021.04 - 2023.09
Doctor of Pharmacy - Pharmacy
Jaya College of Pharmacy
Internship - General Medicines, Surgery, Pediatrics, OBG
Hindu Mission Hospital
Clerkship - General Medicines, Surgery, Pediatrics, OBG
THIRUVALLUR GOVERNMENT HOSPITAL
Registered Pharmacist at Pharmacy Council of India
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