Tarundeep Kaur
Team Manager, Pharmacovigilance, Parexel
- Role
- Team Manager at Parexel
- Location
- Chandigarh, CH, IN
- LinkedIn followers
- 500 followers
About Tarundeep Kaur
A “Performance Driven Professional” with 7.5+ years of prolific experience in Pharmacovigilance that includes- regulatory medical writing, ie, preparation of aggregate reports like PBRERs/PSURs, Addendum to PBRER/PSUR - preparation of reports originating from signal detection and evaluation activities, product quality complaints/Health Hazard Evaluation (HHE) reports, Labelling justification documents, and Risk Management Plan (RMP)- quality review of above mentioned aggregate reports- single case processing, ie, coding of ICSRs of all case types (serious, nonserious, spontaneous, clinical studies, and solicited programs)- exposure to regulatory authority database dealing with the management of duplicates (identification, merging and nullification)With almost 8 years of extensive experience, I have worked in almost all sphere and horizons of PV field and have worked with some of the major Pharmaceutical Companies around the globe. I have worked in multiple therapeutic areas such as Oncology, Infections and Infestations, Dermatology, Cardiovascular, Rheumatology, Immunology/Autoimmune Diseases, Metabolic disorders, Hematology, Virology and Psychiatric and CNS Disorders. Maintain an excellent knowledge of the safety profile of the assigned products, labeling documents, data entry conventions and guidelines and international drug safety regulations including - ICH guidelines, Volume 9A/New PV legislation, and US FDA guidelines. I had an opportunity to explore my knowledge in different buckets of the processes and have handled key roles and responsibilities.
Experience
Team Manager
Feb 2017 — Present · Chandīgarh, IN
Education
Panjab University
Master of Pharmacy
2006 — 2008
Maharshi Dayanand University
Bachelor of Pharmacy (B.Pharm.)
2002 — 2006
Skills
- Medical Writing
- Pharmacology
- Psur
- Clinical Operations
- Gcp
- Regulatory Submissions
- CRO
- Management
- Clinical Trials
- Ich Guidelines
- CRO Management
- Pharmaceutics
- Pharmaceutical Industry
- Sop
- Drug Safety
- Data Analysis
- Meddra
- Pharmacovigilance
- Regulatory Affairs
- Aggregate Reports
- Clinical Research
- Ich-Gcp
- Psurs
- Life Sciences
- Clinical Data Management
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