Open To Work
KISHORE VENKATRAMAN K
Patient Safety Associate 2
Krishnagiri
Summary
Experienced Patient Safety Associate II with over 5 years in pharmacovigilance, demonstrating expertise in Literature case processing. Successfully managed case processing activities, utilizing the IVP database, Argus Safety database and MedDRA coding for various sponsor projects. Recognized for enhancing workflow efficiencies and maintaining compliance with regulatory standards.
Overview
3
3
Certifications
9
9
years of professional experience
Work History
PATIENT SAFETY ASSOCIATE II
PAREXEL
03.2022 - Current
- Handling management of ICSRs of all case types (spontaneous, clinical studies and solicited and unsolicited programs), which includes:
- Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labelling documents (such as Summary of product characteristics (SmPC), Company core data sheet (CCDS), Investigator Brochure (IB) etc.), writing case summaries, assessing causalities, and writing company comment if required.
- Trained in Medical Dictionary for Regulatory Activities (MedDRA) coding in accordance with “MedDRA Term Selection: Points to Consider.” Trained in handling the ERP systems (Enterprise Resource Planning).
- Literature experience: Processing of literature cases including cases from medical journals abstracts, poster presentation, literature summary cases and full literature articles including clinical cases (interventional and non-interventional case studies) and spontaneous reports.
DRUG SAFETY ASSOCIATE I
IQVIA
02.2021 - 03.2022
- Prepare accurate and complete narrative and perform Data Entry by coding all adverse events, medical history, concomitant medications, suspect products, indications, and laboratory tests according to the appropriate dictionary (E.g., MedDRA, WHO-DD).
- Interacting with the sponsor to clarify case related discrepancies and contact the CRA’s/reporters for follow-up store solve all discrepancies as and when needed.
CLINICAL PHARMACIST INTERNS
KRISHNAGIRI GOVT. HEADQUARTERS HOSPITAL
01.2019 - 12.2019
- To assist the physicians and other health care professionals in providing appropriate treatment and monitor adverse effects if any in both outpatient and in-patient department.
- Providing evidence-based information and advice about the safe and effective use of medications.
- Recognizing untreated health conditions that could be managed with Medication therapy. Monitoring patient progress with medications and making relevant recommendations to change.
- Provide patient education and counselling related to their illness, and treatment medications and its adverse effects to enhance medication adherence and quality of life.
PHARMACIST
SRI SARASWATHI ORTHO CLINIC
01.2017 - 01.2019
- Managed pharmacy operations, stock levels, and hospital requirements to optimize patient care and operational efficiency.
- Tracked medication usage and streamlined inventory management using pharmacy management software systems.
- Engaged in part-time work in various roles
Education
DOCTOR OF PHARMACY-PHARM.D -
PADMAVATHI COLLEGE OF PHARMACY
TAMILNADU01-2019
CLASS 10+2 - undefined
SRI VIJAY VIDYALAYA
KRISHNAGIRI01-2013
Skills
SOFT SKILLS
Excellent interpersonal skills and communication skills
Excellent Organizational skills, observation, and attention to detail
Coaching / Training and being a good mentor
Technical and Administrative skills
Highly collaborative and outstanding team player
Handle multiple tasks, flexibility, and ability to work under pressure effectively and efficiently
Prioritizing work based on deadline
Active listening
Proficient fluency and grammar in English with excellent communication skill
Highly motivated and positive attitude to learn from criticism and committed to work
HARD SKILLS
Thorough knowledge on ICH-GCP guidelines, FDA, and EMA regulations
Ability to stick standard operating procedures (SOPs) and company specific procedures
Excellent proficiency in office suite (PowerPoint, Excel, Outlook, and Word)
Research skills and analysis of data
Data handling and management, study document handling and documentation Well versed with various phases of clinical trial
Certification
Registered pharmacist in pharmacy council state of Tamil Nadu 2021.
RESEARCH WORK
Retrospective study on epidemiology pattern and protocol for the management of snake bite followed by preventive strategies and first aid measures for the community.
Work Preference
Job Search Status
Open to workWork Type
Full TimeSalary Range
₹45000/yr - ₹200000/yrTimeline
PATIENT SAFETY ASSOCIATE II
PAREXEL
03.2022 - Current
DRUG SAFETY ASSOCIATE I
IQVIA
02.2021 - 03.2022
CLINICAL PHARMACIST INTERNS
KRISHNAGIRI GOVT. HEADQUARTERS HOSPITAL
01.2019 - 12.2019
PHARMACIST
SRI SARASWATHI ORTHO CLINIC
01.2017 - 01.2019
CLASS 10+2 - undefined
SRI VIJAY VIDYALAYA
DOCTOR OF PHARMACY-PHARM.D -
PADMAVATHI COLLEGE OF PHARMACY