Safety Officer Data Entry

Mintu Augustine

*** ******* **** *****, ******

Phone: +1-343-***-****

Email: ******************@*****.***

PROFILE

Dedicated and enthusiastic Drug Safety Associate with knowledge of service delivery and proven multitasking abilities.

Experienced in preparation of drug profiles, disease awareness and monitoring leaflets.

Safety Associate endeavoring an advancement in the career, to work in an organization which gives ample of opportunity to showcase my talent and experience in the best possible, effective and in an ethical manner.

Process ICSRs according to applicable regulations, guidelines, Standard Operating Procedures

Monitored drug therapy regimens for dose adjustments, cost effective analysis, medication errors, adverse drug reactions, contraindications, and drug interactions.

Generating queries pertinent to the case, performing quality review, assisting with review and reconciliation of applicable reports, driving case closure, requesting translations, and ensuring ICSR are processed within assigned timelines.

Provided adequate and appropriate counselling to patients on the importance of adherence to medications, its route and time of administration, and instructions on the correct use of specific medication devices.

Skilled in retrieving, analyzing, interpreting, and formulating drug information for answering drug information queries from various health care professionals.

Address emails from different stakeholders and customers supporting ICSR activities within timelines and seek clarifications where appropriate (Local Safety Officer (LSO), Pharmacovigilance Physicians (PVP), Customer POCs, safety operational mailbox, etc.)

TECHNICAL SKILLS

Basics of SPSS.

Adverse event reporting

Pharmacovigilance

MedDRA

ARISg Database

Pharmacy Practice

Microsoft Office Suite including Word, Excel, PowerPoint, One Note, One Drive, Access, Project, Outlook.

Technical Writing, emails, technical documentation, client relation

Database management

Data analytics, documentation, and report submission.

STRENGTHS

Identify areas of improvement for self/team and participate in continuous improvement of project.

Specific processes and procedures by identifying and implementing efficiencies in workflow and perform data entry for tracking, coding relevant medical terminology, writing descriptive narratives,

Contribute to innovation and process improvements.

Ensure compliance to quality standards in achieving project and customer deliverables.

Always approachable and supportive for team activities.

Work towards ensuring your individual training plan and training transcript is reconcilable.

Familiar with Leadership and team skills that support a collaborative workplace.

Ability to organize and present data in a clear and concise manner.

Excellent written and verbal communication skills as well as strong interpersonal skills.

Calm and professional under pressure and understanding project needs.

Multitasking, prioritization, and complaint resolution

Time management, team-oriented and cooperative.

Adaptability, attention to detail and creativity.

Excellent decision-making ability and leadership qualities.

WORK EXPERIENCE

Safety Associate, IQVIA RDS 2020 June – 2023 Jan

Process ICSRs according to applicable regulations, guidelines, Standard Operating Procedures

Monitored drug therapy regimens for dose adjustments, cost effective analysis, medication errors, adverse drug reactions, contraindications, and drug interactions.

(SOPs) and project requirements as directed by operations team member or manager.

Case processing and bring them to the attention of Manager.

Address emails from different stakeholders and customers supporting ICSR activities within timelines and seek clarifications where appropriate (Local Safety Officer (LSO), Pharmacovigilance Physicians (PVP), Customer POCs, safety operational mailbox, etc.)

Contribute under guidance of manager to individual deliverables in the field of Safety operations or other service lines as appropriate.

Active participation in Subject Matter Expert (SME) and mentoring programs.

Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.

Writing and performing user acceptance tests for system enhancements and modifications. Ability to support UAT/CVT activities and related user testing documentation as applicable.

Expertise in disease and drug-based counselling, including guidance for lifestyle modifications to ensure therapeutic efficacy of drugs administered for a given disease/clinical condition.

Skilled in interpreting selected laboratory results (as monitoring parameters in therapeutics) of specified disease states.

INTERNSHIPS

Completed 1 Year of internship at KMCT Medical College Hospital, Mukkam, Kozhikode in the following departments.

JULY 2019 TO SEPTEMBER 2020

Cardiology

Nephrology

OBG

Neurology

Dermatology

Emergency Medicine

Orthopedics

ENT

Pediatrics

PUBLICATIONS, DOCTORAL THESIS

1. Case Report on Pemphigus Vulgaris. World Journal of Pharmaceutical Science, 2020; 8(09).

2. A review on COVID 19 Pandemic. European journal of Biomedical and Pharmacy Practice, 2020.

3. Case report on “Glossopharyngeal Neuralgia”. World Journal of Pharmaceutical Science,2020;8(9).

4. Case report on "Acute axonal neuropathy associated with Wernicke’s encephalopathy". IJOPP, 13(4),2020

CURRENT MEMBERSHIPS IN PROFESSIONAL ORGANISATIONS

Kerala State Pharmacy Council Member

LICENSES AND CERTIFICATIONS

Kerala State Registered Pharmacist, 2020

AWARDS AND HONORS

Received Spotlight award for Actively involving in team meetings for scenario-based discussions.

Received Spotlight award for Efficiency and quality of above expectations. A good team player.

Always delivered more than 100% productivity and with very good case quality, 2022.

THESIS WORK

“Assessment of sleep quality and quality of life among Hypertensive population: A community Based study”

POSTER PRESENTATIONS

Presented a poster entitled “Impact of Patient Counseling in Knowledge, Attitude and Practice among COPD patients.”

SEMINAR & WORKSHOP

One-day seminar on Basics of Research Methodology held on 14th March 2019 organized by the Department of Pharmacy Practice and IQAC, National College of Pharmacy, Manassery, Calicut, Kerala.

International Scopus Indexed Conference on “INNOVTING THE PHARMAVERSE: NEW VISTAS AND AVENUES IN PHARMACEUTICAL & CLINICAL DOMAIN” organized by Krupanidhi College of Pharmacy, Bengaluru, on 08-09 November 2019.

5th International Conference on Clinical Pharmacy” INNOVATIVE APPROACHES IN DELIVERING PHARMACEUTICAL CARE” organized by Manipal College of Pharmaceutical Science, Manipal, on 11-12 January 2020.

EDUCATION

Doctoral Degree (Doctor of Pharmacy) Pharm D

National College of Pharmacy, KMCT, Calicut, India

Kerala University of Health Sciences

2014 – 2020

REFERENCES

1.Dr. Sujith Varma, Principal, National College of Pharmacy, Calicut.

Email: **************@*****.***

2.Dr. Shamnas M, HOD Pharmacy Practice, National College of Pharmacy, Calicut.

Email: *********@*****.***

3.Mr. Naresh Vadala, Ass Manager, Pharmacovigilance Operations/ Management/ Client Service at IQVIA RDS (India)

Email : ******.******@*****.***

4.Shilpa Mukundan, Safety Associate, at IQVIA RDS

Email: ******.********@*****.***

Contact this candidate