Safety Clinical Research

BHARANIDHARAN INDRAKUMAR

***, ****** ******, *********, ** N2E3T8 C: 519-***-**** *******.****@*****.***

SUMMARY

Experienced Safety Associate with a demonstrated skills and experience of working in hospital & health care industry. Skilled in Clinical Research, Protocol Writing compliant with the good clinical practice, Research methodology, and Microsoft office. Efficient in operational management with a Doctor of Pharmacy (Pharm.D) graduation. Currently pursuing postgraduate diploma in healthcare administration and service management at Conestoga College.

EXPERIENCE

Worked as Drug Safety Associate from January 2019 to December 2019 at IQVIA PVT LTD, Karnataka, India.

Key Responsibilities

Receive, triage, review and process Lifecycle Safety data from various sources on time, and quality standards.

Perform data entry for tracking and Lifecycle Safety databases, coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case.

Ensuring reports are sent to the customer within assigned deadlines.

Perform submission to the sponsor.

Sending submission package.

Worked as Drug Safety Associate trainee from July 2018 to December 2018 at IQVIA PVT LTD, Karnataka, India.

Key Responsibilities

Receive, triage, review and process Lifecycle Safety data from various sources on time, and quality standards.

Perform data entry for tracking and Lifecycle Safety databases, coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case.

Ensuring reports are sent to the customer within assigned deadlines.

Worked as a part-time research assistant from August 2017 to May 2018 at Clinical research department of Sri Ramachandra institute of higher education and research.

Key responsibilities:

Assist in writing study protocols.

Handle subject’s data and classify subject into different arms based on the study criteria.

Assist principal investigator of the designated study and coordinate with the investigator on regulatory submission.

Ensure to manage all regulatory document that needs to be submitted to the regulatory authorities.

EDUCATION AND TRAINING

Pursuing healthcare administration and service management at the Conestoga College in Waterloo, Ontario.

Studied PHARM.D (Doctor of pharmacy) from 2012-2018 at Sri Ramachandra institute of higher education and research in Chennai, India.

Registered Pharmacist under Tamil Nadu pharmacy council, Tamil Nadu, India.

PUBLICATIONS:

"QUALITY OF SLEEP AND QUALITY OF LIFE OF SOUTH INDIAN PATIENTS ON MAINTENANCE HEMODIALYSIS – A STUDY ON THE IMPACT OF SLEEP EDUCATION"- under process yet to be published.

SKILLS

Worked with Argus safety data base.

Clinical trial management system database.

Good clinical practice (GCP).

Electronic trial master file (eTMF).

Medical writing.

Narrative writing.

Clinical pharmacology.

Clinical trial methodology.

Microsoft word, Excel and PowerPoint.

Project support.

Regulatory compliance.

LANGUAGES KNOWN:

English

Tamil

Telugu.

Availability: Any shifts

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