**** ***** ****** ***

Mississauga, ON, Canada

L*R 0C5

adx1xr@r.postjobfree.com

+1-647-***-****

www.linkedin.com/in/kalyani-

sharma-a341101b3

Kalyani Sharma

Drug Safety Specialist

Work Experience

Handling of AB-cube, Sapphire and Argus and Smartrace software. Assessment of case reports for seriousness, causality and expectedness Well versed with Pharmacovigilance concepts and reporting guidelines Knowledge of case triage, case narrative writing, performing labelling/ listedness and causality determination.

Understanding of drug development process including drug safety and different phases of clinical trials

Knowledge of GVP Module VI and ICH Guidelines

Knowledge about Sections of Aggregate Reporting (PBRER and PSUR) Dispensing medicines and providing instructions to OPD/IPD patients Managing stores and stocks of medicines

Registering patient for OPD, collecting fee and allotting prescription slip Keeping online records of medicines with Data entry operator Coordinating with Drug Distribution Center

Carrying out routine treatment, assistance in examination of emergency cases

Registering patient for OPD, collecting fee & alot prescription. Monitoring of short expiry drugs, inventory inventory management and disposal of expired drugs

Administration of dressing, sterilization of mate

Handling of QC Instruments

Testing of Drugs

Drug Safety Specialist

PharmaLex Private India Limited

March 2021 to April 2023 (2 years, 1 months)

Executive

Sujay Life Sciences India

November 2014 to January 2017 (3 years,)

Quality control

Stabilty Analyst at Ranbaxy Labs Ltd, Paonta Sahib India Aug 2013- Aug 2014 (1 year)

About Me

Intend to build a career with leading corporate with committed and dedicated people. I am willing to work as a key player in challenging and creative environment, to become a successful professional. Completed post graduation dissertation titled “formulation and evaluation of pulsatile drug delivery system for the treatment of nocturnal asthma" PGDM in Nursing and Healthcare Management

Institution: Northern College, Toronto, Canada

Year of pursuing: May 2023

Master of Pharmacy In Pharmaceutics

Institution: H.I.P.R., Dehradun, India

Year of Post Graduation: 2020

Bachelor of Pharmacy

Institution: M.D.U. Rohtak India

Year of Graduation: 2013

Education History

Good oral and written communication skills

Good analytical and interpretation abilities

Practical knowledge of MS Word, Excel and PowerPoint presentation Quick learner

Goal oriented

Punctual

Reliable

Committed

Skills

Assessment of case reports for seriousness, causality and expectedness Well versed with Pharmacovigilance concepts and reporting guidelines Knowledge of case triage, case narrative writing, performing labelling/ listedness and causality determination.

Understanding of drug development process including drug safety and different phases of clinical trials

Learning GVP Module VI and ICH Guidelines

Learning about Sections of Aggregate Reporting (PBRER and PSUR) Professional Skills: Pharmacovigilance

Completed Qualified Pharmacovigilance Professional Training in case processing from Academy of Clinical Intelligence (A Pharmacovigilance Training Management Company), Chandigarh India Registered Pharmacist Under Pharmacy Council of India. Review paper- Pulsatile drug delivery system and various approaches used to design PDDS, published in JETIR, Jun 2020.

International seminar on “How to improve the quality of phytomedicines” by M.M. College of Pharmacy on 25th Jun 2020.

Workshop on “Early career researchers focusing on scholarly publishing, peer review, ethics and plagiarism, science communication and careers” by ACS and DST Govt. Of India at UCOST, Vigyan Dham, Dehradun which was held on 25th Nov 2019.

“National seminar on emerging trends of clinical research and pharmacovigilance in India: A choice for Pharma graduates”, 20th Apr 2019, At Uttarakhand Technical University, Dehradun. Training program on “Quality control and analytical techniques” organized by Department of Biotechnology & Chemistry, at Uttaranchal College of Applied and Life Sciences (UCALS), U.T.U., Dehradun from 22nd Feb – 27th Feb 2019.

Workshop on “ADR reporting in pharmacovigilance and medical coding”, by Uttaranchal Institute of Pharmaceutical Sciences, Dehradun (Uttarakhand), which was held on 1st Feb 2019. Certificates:

Publications:

Conferences/ Workshops:

Volunteer Work, Awards, Affiliations