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Fresher Pharmacovigilance Executive Resume Sample



Name of the Candidate:[Private]
Name of the Post Applied:Pharmacovigilance Executive
Job related skills / software:Responsible for co-ordination with vendor for new development in safety database, Responsible for change management process and co-ordination.
Sub Category:Pharmacovigilance
Years of Experience:0 years
Salary Expected per Month(Rs):20,000 to 25,000
Highest Qualification attained:M.Pharm. : Master of Pharmacy
Major / Specialization:Pharmacology
Email Id:[Private]
Are you looking for job now?:No
Can the recruiter contact you?:No
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Resume Format / CV Sample Template / Example / Model :


Mehul Patel
E-mail : patelmacav AT yahoo.com
Address : C-9, Tirupati Society, New Ranip, Ahmedabad,Gujarat
ContactNo : +91-7383250024;+91-8460553905

To achieve a challenging and meaningful positiont outilize my skills for the development of organization as well as to explore my theoretical & practical knowledge.

** Pharmacovigilance
** ClinicalResearch/ Medical Affairs

Organization : LambdaTherapeutic Research Ltd., Ahmedabad, India
PositionHeld :Research Associate

· JobResponsibilities :
PVSystemadministrator(From18th Jan-2016 totill date)
** Single pointofcontactwith safetydatabaseservice provider.
** Responsible for co-ordination with vendor for new development in safety database.
** Responsible for change management process and co-ordination.
** Ensure the validation and testing deliverables are written in compliance with this SOP and other applicable SOPs, WIs or guidelines.
** Contribute to the criticality and risk & impact analysis.
** Responsible for ensuring that Incident Management is in place and is appropriate for supporting the IT systems.
** Maintenance of Company’s Standard Code Lists and project specific data.
** Ensure the validated state of the application is maintained.
** MedDRA upgradation.
** Management of User access requirements and changes to application settings.
** Voiding and nullifying cases in the database after QPPV authorization.
** Access to Database on behalf of QPPV
** Ensure the development, validation, operation and change management of the safety database and maintains oversight of the related processes and procedures to ensure that all adverse events reported to the MAH are recorded and accessible.

EMC Datapharm- Data Management System (From 1st Jul-2016 totill date) :
** Regular updating SmPC and PIL on EMC Datapharm
** Regular updating RMM (Risk Minimisation Material) on EMC Datapharm

Regulatory Update - Safety variation and Pharmacovigilance updates. (From 1st Aug-2016 to till date) :
** Periodically checking the websites for safety variation and Pharmacovigilance updates.
** Preparing and Maintaining of Regulatory website monitoring tracker and safety variation tracker

AdditionalResponsibilities :
** Preparation, revision, review of SOPs, Wls, templates, guide and guidance training documents
** Communication of urgent safety issues to Line manager and QPPV
** Ensure communication with all relevant people is of a high professional standard, and that records of both internal and external communication are maintained
** Ensuring compliance (quality, procedures, regulations, timeliness, consistency) with local regulations and Company’s global Pharmacovigilance requirements
** Deliver training to new joinee and team as per requirement
** Work with the ICSR team leader to escalate issues or tasks outside the normal scope of work.
** Support group leader for timely submission of ICSR in order to achieve 100% regulatory compliance.

01-January-2015 to 15-January-2016 :
· NameoftheOrganization :DivyamHospital, Surat
· PositionHeld :ClinicalResearchCoordinator

01-July-2014 to 30-December-2014 :
Name of the Organization :Divyam Hospital, Surat
PositionHeld :Clinical Research Coordinator Trainee

v SummaryofJobResponsibilitiesatDivyamHospital :
** Screening patient database
** Recruiting, Scheduling visits and retention of patients
** Study start up and Site initiation
** ICF presentation and Subject Recruitment Process
** Patient follow-up visits
** CRF filling and cross checking
** Regulatory and Ethics Committee submissions and communication
** Collection of lab reports according to GCLP
** Maintain and update study logs and Site Master File
** Safety reporting to sponsor and Ethics Committee
** Archival of study documents after the study completion.

Studyspecific audits& Facility audits by different Sponsors,CROs.

25-April-2013 to 20-June-2014 :
Name of the Organization :Skypill Pharmaceuticals, Surat
PositionHeld :Business Executive and Executive of Product Management

01-Oct-2012 to 25-April-2013 :
Name of the Organization :Bhagwan Mahavir college of pharmacy, Surat
PositionHeld :Assistant professor

07-July-2011 to 30-Sep-2012 :
Name of the Organization :Vidyabharti College of Pharmacy, Umarakh, Surat
PositionHeld :Assistant professor

M.Pharm(Pharmacology) RajivGandhi University 2011 74 %
B.Pharm Veer Narmad South Gujarat University 2009 65 %

MasterofPharmacy(Pharmacology) (2009-2011) “Evaluationof Adaptogenic activity of Glycyrrhiza glabra roots”
2. Bachelor of Pharmacy (2005-2009) “Drug induced Sexual and Dental disease”

** Industrial Training was done in COLORTEX Pharmaceutical, Surat in. In various departments.
** Emerging trends in clinical research sponsored by dept. of science and technology held at garden city college, Banglore, March-2010.
** National level workshop on NMR and MASS spectrometry, sponsored by Rajiv Gandhi University, in PES College of pharmacy in Banglore, Feb-2011.

Book : Evaluation of adaptogenic activity of Glycyrrhiza glabra root (ISBN 978-3-8473-0995-6) {LAP LAMBERT Academic Publishing GmbH & Co. KG}
Book : Anti-Stress and Anti-Oxidant Activity of Morninga Oleifera (ISBN-13: 9783847338055) {LAP LAMBERT Academic Publishing GmbH & Co. KG}.

** Knowledge of database- PvNET,Datapharm, Q-Edge, PrITR
** Detailed Understanding of ICHGCP,Indian-GCP and Schedule-Y
** Knowledge of Regulatory guidelines-ICMR,EMEA,US-FDA,ANVISAandTGA.
** Knowledge of Clinical Trial Operation and Medical Writing
** ComputerKnowledge :WindowsXP/Vista/7,MS-Office.

PersonalDetails :
Gender :Male
Nationality :Indian
MaritalStatus :Married
DOB :12th September,1987.
Languages Known :English,Gujarati andHindi.
Interests andHobbies :Interactionwith newpeople,Music,Readingand Internetsurfing.

Date :
Place  :


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