Data entry, pharmacovigilance, clinical research
Resume:
Rinkal Hapaliya
Email: ac7u4o@r.postjobfree.com
Mob :639-***-****
Red deer, Alberta, Canada
PHARMACOVIGILANCE/CLINICAL RESEARCH PROFESSIONAL
PROFILE
Competent and diligent B.Pharm professional offering a comprehensive experience of 04 years and 03 months in Pharmacovigilance (Drug safety) at Cognizant Technology Solutions, Mumbai, India.
Possessing core competencies in Pharmacovigilance (Drug Safety), Drug Safety Databases, Process training, Medical Monitoring & Safety Monitoring and Clinical Research.
PROFESSIONAL EXPERIENCE
As Process Trainer:
Conduct process training for new joiners and help in their mentorship.
Ensure that all the new joiners are aware of the process and standard work instructions.
Create training plan and applicability matrix for process training.
Maintain data as per the customer guidelines.
Co-ordinate client training team and arranging on boarding training sessions.
Co-ordinate with internal teams to obtain necessary information required for day to day operation.
Perform training need analysis to improve overall quality of the team.
Liaise with client team and help in clarification of queries raised by case processor.
As Quality Reviewer:
Review Quality for 10 percent of cases processed by associates for the particular date.
Ensure that the project meets client SLA.
Taking initiatives for maintaining Quality of the project.
As Case Processor:
Assigned with the responsibility of entire case processing from book in, data entry, all adverse event pulling, coding of all events (by MedDRA v20.1) and drugs (by CPD or WHO DD), labeling, narrative writing to medical review.
Spearheading efforts across verifying overall consistency of cases, assessment of solicited or spontaneous non-serious and serious cases in Global safety data base ARISg (v9.0).
Coordinating with different functional team members, e.g. team leaders, and other health care professionals and QC’S for completion of various cases with accurate consistency and proper validation.
Successfully contributed knowledge and expertise to or lead assigned deliverables in the field of Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
EDUCATIONAL DEVELOPMENT
Qualification
Institute/ Organization
Board/ University
Year
% / CGPA
B.Pharm
Dr.L.H. Hiranandani
College
of Pharmacy
Mumbai
2009-2013
68%
P.G.Diploma in
Clinical Trial
Management
Cliniminds Institute
Mumbai
2013-2014
73%
KEY SKILLS AND STRENGTHS
Quick and attentive learner.
Adaptability to different environments.
Ability to develop good interpersonal relations.
Disciplined & Punctual.
Attention to details.
Ability to manage the failure.
ACHEVIMENTS
Selected as Process Trainer and Quality Reviewer. (Certified by client).
Awarded with the certificates for outstanding performance and knowledge in the team.
Awarded with an extra monetary incentive for the outstanding performance.
EXTRA CURRICULAR ACTIVITIES
Conferences/Workshops attended
oVolunteer for one day national seminar on ‘technical aspects in pharmaceutical researches’.
oParticipation in Pharmazeal national level poster and working model competition
Topic: Effect of pharmaceutical waste on environment.
oParticipation in Zonal Level young Pharmacist innovative project award
Topic-Photodynamic therapy.
oParticipation in Rx Tech Fest
Topic- Needle free injection and White tea (2nd Prize) - poster presentation.
oOne month training at SandoZ.
Miscellaneous
oDelivered various seminars on academic topics at institutional level.
oParticipated in various social awareness programs during the academic curriculum.
oParticipated in various sports & cultural programs at school & college level.
oOrganized many cultural as well as professional events at college level.
References
Kara Henken (Director – Abbvie, USA)
Dinakaran Munusamy (Manager – Teva Pharmaceuticals, Toronto)
Rinkal Hapaliya
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