Isha Sharma

Address: B-**/* BDA Flats, MIG- Domlur, Banglore

Contact No: 910*******

Email: acurjb@r.postjobfree.com

Summary

Expertise areas are Pharmacovigilance, Training and Development, GCP Compliance, Clinical Monitoring and Project Management.

Proven team player; target and achievement oriented with an ability to take up challenges and perform in changing work environments.

Present: Project Management Executive at Actimus Biosciences Pvt Ltd (CRO for BA/BE Studies)

Total 1 year and 6 months of Experience (Pharmacovigilance Associate – Since Sep 2012 – Feb 2014 at APCER PHARMA, New Delhi) as a Pharmacovigilance associate

Academic background including Bachelor of Pharmacy (2012) Institute of Pharmaceutical sciences, Kurukshetra University, Kurukshetra.

Key Area of Expertise

Specialties: Pharmacovigilance, Training and Development, GCP Compliance, Clinical Monitoring and Project Management.

Handling Clinical Trials which includes:

Permission for DCGI approvals for study molecule on site

Import License/Possession License for Study molecule

Study Initiation Notification

Submission of Monthly Reconciliation to DCGI, CDSCO

Project Scheduling, slotting the study in clinic

Training on GCP compliance and regulatory requirements

Archiving of study documents in master files

Professional Experience (Approximately 2 Years)

Period : Sep 2012 – Feb 2014

Company : APCER PHARMA, New Delhi

Designation : Drug Safety Associate

• Data Entry and Quality Check of ICSRs in APCER’s pharmacovigilance database (ARISg) and other case management activities.

• Well versed in narrative writing for ICSRs (Literature and ASPRs).

• MedDRA coding of adverse event (AE) and drug coding.

• Assessment of case reports for seriousness, causality and expectedness.

• Literature search and sending the full text literature request to the British library.

• Management of Compliance with the Company Standard Operating Procedures and regulatory requirements.

• Maintain project specific working files, case report files and project central files.

• Assist with Drug Safety Specialists in case related activities as required.

• Evaluation of the literature abstracts received from RPS (Reaction Pharmacovigilance Service) and preparation of the FTA request mail for the same.

Company : Actimus Biosciences Pvt Ltd

Designation : Project Management Trainee.

Planning for upcoming new projects.

Assists in Research project to team.

Collects data as required by the project.

Maintains study timelines.

Coordinate with study sites.

Maintains effective and ongoing communication with sponsor and sites.

Schedules, conducts, and documents assigned audits of the Company’s projects and operational processes in accordance with approved procedures and schedules:

Period : Nov 2015 to Present

Company : Actimus Biosciences Pvt Ltd

Designation : Project Management Executive.

Permission for DCGI approvals for study molecule on site

Import License/Possession License for Study molecule

Study Initiation Notification

Submission of Monthly Reconciliation to DCGI, CDSCO

Project Scheduling, slotting the study in clinic

Training on GCP compliance and regulatory requirements

Archiving of study documents in master files

Assisting the site for submission of all essential documents to the Institutional review board (IRB) for their review process.

Manage safety reporting - review SAEs, ensure all stakeholders are notified and that all safety related company procedures and regulatory requirements are complied.

To assess AE & SAE with respect to guidelines.

Ensure Site related Audit/Inspection issues are resolved and Corrective Actions and Preventive Actions are implemented.

Manage the shipment of all clinical trial supplies and investigational product.

Maintenance of all essential pre and post documents as well as various logs and investigational product (IP) accountability at site.

Academic qualification

2012: Bachelor of Pharmacy Institute of Pharmaceutical sciences, Kurukshetra University, Kurukshetra

2008: Senior secondary from Kendriya Vidhyala (C.B.S.E. board) Ambala cantt.

2006: High school from Army school (C.B.S.E. board) Sri Ganganagar.

conferences & training

Have done a course on Software Quality Assurance from INIT CALL TECHNOLOGY. IT SKILLS

Technical software ARISg5

Command on operating systems MS Office, i.e. MS-Excel, needed for macro & micro analysis with large data handling, MS-Word, Power Point.

Command on scientific database, i.e. Pubmed, FDA, EMA and Clinicaltrial.gov

Additional skills

Operating System: Microsoft Office Excel, Microsoft Office Power Point, Internet Browsing

personal information

Date of birth: 10 Feb 1990

Father’s Name: Anil Kumar Sharma

Nationality: Indian

Marital status: Married

Permanent Address: 17. Dayal Bagh, Mahesh Nagar, Ambala Cantt

Hobbies: Golf, Volley Ball Explore new places

Interpersonal Skills: Team work, Responsible, Hard working, Self motivated,High Energies, Open to learn new things

declaration

I do hereby declare that the above information is true to the best of my knowledge.

Ms. Isha Sharma

Contact this candidate