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Drug Safety Associate

Location:
Chandigarh, Chandigarh capital, India
Posted:
November 05, 2020

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Resume:

DR. NAVPREET KAUR

INDIA adhkla@r.postjobfree.com (*36) 750-766

OBJECTIVE 3 YEARS EXPERIENCED DRUG SAFETY ASSOCIATE SEEKING OPPORTUNITY TO FACILITATE GLOBAL PHARMACOVIGILANCE SERVICES INCLUDING CASE INTAKE, CASE PROCESSING, EMA, E2B R3, PATIENT SUPPORT PROGRAMS (PSPS) BY UTILIZING MY KNOWLEDGE AND SKILLS IN PHARMACOVIGILANCE.

EDUCATION MAHARISHI MARKANDESHWAR UNIVERSITY, MULLANA, HARYANA BACHELOR OF DENTAL SURGERY

Graduation Date: October 2017

WORK

EXPERIENCE

PAREXEL International Pvt. Ltd. Chandigarh

Drug safety Associate-I Jul 2020 – Current

• Effectively handled ICSRs, including literature reports, Legal cases, health authority reports and spontaneous reports, Patient Support program (PSPs)

• Experienced in managing Individual Case Safety Reports (ICSRs) of various case types (spontaneous, clinical studies, solicited programs and literature cases). Familiar with international drug safety regulations (including ICH guidelines on safety and efficacy, US FDA guidelines, CIOMS, New EU PV legislation).

• Trained in maintaining a good working knowledge of the AE safety profile of assigned products and labeling documents

• CAPA experience in escalation, investigations, impact analysis, corrective actions and effective measures and expertise in writing RCA’s (Root Cause Analysis).

• Trained and Mentored new recruits in the team.

• Attended project team meetings, teleconferences and video conferencing as per team and client requirements.

•Responsible for interacting with clients including country specific Health Authorities, stakeholders, health care professionals for verifications of ICSR related issues. PAREXEL International Pvt. Ltd. Chandigarh

Pharmacovigilance Scientist

Nov-2017-Jun-2020

• Effectively handled ICSRs from connected and non-connected sites, including literature reports, health authority reports and spontaneous reports, Patient Support program (PSPs)

• Performed triage, Prioritization and further processing of serious and non-serious Spontaneous/Clinical ICSRs along with identifying duplicate or invalid ICSR in Argus safety data base and handling as per relevant SOPs also ensured to capture accurate data to the database as per source document.

• Conducted for generating and forwarding appropriate queries and request for clarification of discrepant data or additional data to the concerned party, client or responsible site for handling such queries.

• Ensured 100% quality review of all data entered in AEGIS Database for completeness and accuracy with reference to source documents as per applicable SOPs

• Accurate data capture of Spontaneous/Clinical ICSR.

• Trained in maintaining a good working knowledge of the AE safety profile of assigned products and labeling documents

• Assured and maintained compliance with regulatory and local/global SOP timelines using proactive work-flow management.

• Interacted with internal or external contacts to resolve issues related to the processing of ICSRs and can respond to clients/customers in a timely manner

• Performed MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”, where applicable

• Familiar with international drug safety regulations (including ICH guidelines on safety and efficacy, USA FDA guidelines, New EU PV legislation)

Maharishi Markandeshwar University, Mullana

B.D.S Intern August 2016 – October 2017

• Accountable for diagnosing and providing appropriate dental treatment to patients including dental cleaning, root canals, extractions and oral prophylaxis.

• Educated patients and parents of patients on maintaining proper oral health. PAGE 2

• Communicate with dental staff and seniors of our department regarding patient treatment plans.

• Prescribe medication as necessary.

• Accountable for documenting all medications, diagnosis, treatment plan.

• Assisted seniors and staff in various surgeries. PARTICIPATION

& INITIATIVES

• Attended a Scientific Lecture on “Current Opinions in Management of Biofilms and Periodontal Diseases” at MMCDSR, Mullana on 23rd October,2015.

• Participated in Continuing Dental Education Programme on “Final Protocol in Endodontic” by Dr. Anish Vishnu Naware (Consultant Endodontist, Mumbai) at Committee Room, MMU, Mullana on 3rd October 2016.

• Participated in Continuing Dental Education programme on “Oral Pathology-Clinical Correlations” held at Maharishi Markandeshwar University, Mullana- Ambala on 2nd December 2016.

• Attended Continuing Dental Education Program on “Esthetics Extravaganza” conducted by Indian Dental Association Branch Mohali and Indian Academy of Aesthetic and Cosmetic Dentistry at Chandigarh on 21st May 2017.

• Participated in Poster competition organized by Department of Public health dentistry on “WORLD NO TOBACCO DAY.”

• Attended a symposium on “Tobacco-Usage and Interventions” organized by Department of Public Health Dentistry held on 26th May 2017.

TECHNICAL

SKILLS

MS Office Suite: Word, Excel, Power Point

Databases: AEGIS, ARTEMIS, Argus Safety, AWARE,PRIMO Operating Systems: Windows 98, XP, Vista, 7, 8, 10, MacOS Mojave. LEADERSHIP

AND

TEAMWORK

PPL-5 Women Cricket Tournament, Parexel International Pvt Limited. Vice-Captain

Student Council, Maharishi Markandeshwar University, India Member June 2015 – July 2016

The Mega Talent Show events, Parexel International Pvt Limited. Event Manager for Floor Decoration and Rangoli September 2018 – July 2019 COMMUNITY

INVOLVEMENT

Smile Foundation (NGO), India

Sold self-made paintings to help underprivileged and homeless children June 2009 OTHER SKILLS Communication and Team Skills

Ability to produce concise, organized reports, proposals, and memos Ability to work in a team, collaborate and adapt quickly to the demand Languages

Fluent in English, Hindi and Punjabi



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