SONALI KANWAL
Kankhal
Summary
To utilize my technical as well as communication skills, to create quality value and maximum my experience for the betterment of my career, thereby developing a successful attitude towards life and utilize my emerging talent by being a part of a reputed drug safety organization.
Overview
5
5
years of professional experience
Work History
Drug Safety Associate-II
Parexel International Pvt Ltd
10.2020 - Current
- Case processing
- Experienced in the management of the regulatory information of Medicinal Products/Vaccines/Devices/ Nutraceuticals which includes performing the data entry in the Veeva Vault
- Experienced in reviewing the lateness reason and responsible organization for each workflow activity (inbound receipt and triage, adverse reaction information system global to outbound submissions tracking) in accordance with the conventions, guidelines, and standard operating procedures
- Assigning the overall lateness reason and responsible organization for late ICSRs
- Reassessing and changing the lateness reasons or responsible organization if assessed incorrectly by the Drug Safety Associate (DSA) at the time of case closure at his/her end
- Experienced in handling ad-hoc requests from Client regarding compliance investigations, as applicable
- Awareness in the management of ICSRs of all case types (spontaneous, clinical studies and literature cases) which includes: Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities
- Data entry of ICSRs in the safety database
- Medical review of ICSRs includes determining the expectedness of adverse events against various labeling documents (such as SPC, CDS, IB etc.), writing case summaries, assessing causalities if required and writing company comment if required
- Familiar with MedDRA coding in accordance with 'MedDRA Term Selection: Points to Consider'
- Maintaining a good working knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including: ICH guidelines on safety and efficacy, FDA guidelines, CIOMS, New EU PV legislation, GVP Modules
- Responding to clients/customers in a timely manner
- Maintaining awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Assistant Professor
Himalayan Institute of Pharmacy and Research
09.2019 - 09.2020
- Wide experience in teaching pharmaceutical courses
- Sound knowledge of general care medicine and infectious care medicines
- Exceptional knowledge of ambulatory and acute care services
- Familiarity with Formulation and delivery of biomacromolecules
- Proficient with instructional techniques
- Ability to teach students from diverse background
- Ability to manage multiple projects to meet deadlines
Education
Ph.D -
SGRR University
Dehradun10.2024
M.Pharm -
SGRR University
Dehradun01.2019
B.Pharm -
DIT University
Dehradun01.2017
Intermediate -
Shivdale School
Haridwar01.2013
High School -
Shivdale School
Haridwar01.2011
Skills
- ARISg
- Veeva Vault
- Argus
- Windows 10
- MS Office
- Communication
- Medical Terminology
- Teamwork
- Attention to Detail
- Leadership
- Analytical Skills
- Problem-Solving
- Time Management
- Interpersonal Skills
Languages
Hindi
English
Educationaltours
- Ipca Laboratories Pvt. Ltd, Dehradun, Uttarakhand
- Indian Glycol Limited, Dehradun, Uttarakhand
- Patanjali Yogpeth, Haridwar, Uttarakhand
Publications
- A Review on Periodontitis and Its Treatment Strategies, JETIR
- Development and characterisation of doxycycline in-situ film for the treatment of periodontitis, Journal of Advanced Scientific Research
Projects
B.Pharm, Sunscreen cream (10 formulations), Design and evaluation of Rosuvastatin loaded with solid lipid nanoparticles M.Pharm, Development and characterization of in-situ film for the treatment of Periodontitis
Training
- 69th IPC, 2017, Chitkara University, Chandigarh
- 70th IPC, 2018, Amity University, Noida
- 13th UCOST, 2018-19, Uttarakhand State Council for Science and Technology, Vigyan Dham, Dehradun
- 4th Annual International Conference (SPER), 2015, DIT University, Dehradun
- Vivimed Labs Pvt Ltd, Haridwar, Uttarakhand, 249408, 06/21/16, 07/20/16
Personal Information
- Father's Name: Mr. Chander Singh Kanwal
- Mother's Name: Mrs. Usha Kanwal
- Date of Birth: 12/30/95
Timeline
Drug Safety Associate-II
Parexel International Pvt Ltd
10.2020 - Current
Assistant Professor
Himalayan Institute of Pharmacy and Research
09.2019 - 09.2020
Ph.D -
SGRR University
M.Pharm -
SGRR University
B.Pharm -
DIT University
Intermediate -
Shivdale School
High School -
Shivdale School
Similar Profiles
Vishalraj SaxenaVishalraj Saxena
STUDY GRANTS ANALYST II at Parexel International Pvt Ltd.STUDY GRANTS ANALYST II at Parexel International Pvt Ltd.
Kammari PriyankaKammari Priyanka
IT Technical Support Specialist II at Parexel International Pvt LtdIT Technical Support Specialist II at Parexel International Pvt Ltd
CHETHAN T.PCHETHAN T.P
RA Associate at Parexel International Pvt LtdRA Associate at Parexel International Pvt Ltd