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Pharmacovigilance Executive Resume Sample, Experience : 11 years

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Name of the Candidate:[Private]
Name of the Post Applied:Pharmacovigilance Executive
Job related skills / software:Reporting of the Adverse Drug Reactions, Updation and Maintenance of Pharmacovigilance Master File, Preparation and maintenance of Safety data Exchange Agreements
Category:Medical
Sub Category:Drug Regulatory Affairs Executive
Years of Experience:11 years
State:Maharashtra
Gender:Female
Salary Expected per Month(Rs):more than 1 lakh
Highest Qualification attained:P.G.D. / PGD : Post Graduate Diploma
Major / Specialization:Marketing International Business
Email Id:[Private]
 
Are you looking for job now?:Yes
Can the recruiter contact you?:Yes
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Resume Format / CV Sample Template / Example / Model :

    

Prabhune.Aparna
Email  : mirashiapparna AT gmail.com

Skills And Abilities  :
** Experienced :A registered pharmacist with +10 years of experience in Regulatory Affairs (International, Indian – Pharmaceuticals {Bulk, Finished Formulations, Devices}, Neutraceuticals, OTC) and Pharmacovigilance. Well versed with CTD format
** Communication Skill :Good written and verbal presentation skills.
** Interpersonal Skills :Able to get along well with co-workers and accept supervision. Received positive evaluations from previous supervisors. Good Team Leader
** Flexible : Willing to try new things and am interested in improving efficiency on assigned tasks.
** Attention to Detail & Hard-working : Concerned with quality. Produce work that is orderly and attractive. Ensure tasks are completed correctly and on time. Aggressive.
** Computer Skills :Application MS-office (MS Word, MS Excel & MS-Power Point), Adobe, Web related Internet surfing.
** Languages Known (Read, Speak and Write) :English, Hindi and Marathi.

Professional Experience :
Senior Manager,Regulatory Affairs
August2013–Present
WOCKHARDT LTD- Mumbai
** Handling of Applications [Registration, Marketing Approvals, Import Licences, Test Licences, Clinical Trail NOC and Report Submissions] for finished formulations (Pharmaceuticals, Cosmetics, Food Products), Bulk Drugs and Devices in India.
** Handling of Post approval variations.
** Maintenance of Track records all the approval received and applications made
** On time Renewal of registrations/ approvals.
** Preparation and maintenance of Quality Documents (SOPs)
** Creation / Updation of packaging materials including Package insert.
** Active Involvement in planning of Regulatory strategy for new product approvals and launch in countries and provide expert advice to marketing / business development w.r.t regulatory perspective on product launch and marketing of products in India.

Manager Regulatory Affairs and Drug Safety :
April 2008 – July 2013
MERCK LTD- Mumbai

Was Responsible for :
** Regulatory activities [Registration, Marketing Approvals, Import Licences, Test Licences, Clinical Trail NOC and Report Submissions - Fillings, follow-up and product life cycle management] for finished formulations (Pharmaceuticals, Food Products and Consumer Health Care Products), Bulk Drugs and Devices for India, Nepal, Bhutan, Bangladesh and Srilanka.
** Post approval variations for submission to respective Health Authorities.
** Co-ordination with Global regulatory colleagues.
** Direct dealing with different parties, mailing required documents to them and solving related problems.
** Maintenance of Track records all the approval received and applications made.
** Preparation and maintenance of Quality Documents (SOPs)
** Creation / Updation of packaging materials including Package inserts for Local/ Global products.
** Review and approval of promotional materials
** Active Involvement in planning of Regulatory strategy for new product approvals and launch in countries and provide expert advice to marketing / business development w.r.t regulatory perspective on product launch and marketing of products in India.

Was also responsible for overall functioning of Drug Safety in India including :
** Reporting of the Adverse Drug Reactions.
** Updation and Maintenance of Pharmacovigilance Master File
** Preparation and maintenance of Safety data Exchange Agreements
** Preparation and maintenance of Quality Documents (SOPs)
** Literature Screening for SAEs
** Website screening for SAEs reported
** Review of Clinical Documents prior submission to DCGI for CT application
** Co-ordination with Global PV Team.

Officer, Regulatory Affairs :
June 2006 – April 2008
KHANDELWAL LABS PVT LTD- Mumbai
** Handled registration of finished formulations for CIS Countries [Kazakhstan, Russia], African Countries [Burkina Faso, Burundi, Cameroon, Dominican Republic, Ethiopia, Ghana, Ivory Coast, Kenya, Mali, Nigeria, Senegal and Zimbabwe], American Countries [Haiti, Jamaica, Trinidad & Tobago, Venezuela] and Asian Countries [Bhutan, Bangladesh, Myanmar, Nepal, Srilanka].
** Handled tenders for Benin, Cameroon, East Caribbean, Ghana and St.Lucia.
** Directly dealt with different parties, mailing required documents to them and solving related problems.
** Maintained Track records all the approval received and applications made to respective Regulatory authorities.
** Handled Export Orders
** Prepared Certificate of Pharmaceutical Products and Free Sale Certificates for submission to State FDAs, required for registration purpose.
** Creation / Updation of packaging materials including Package inserts for Local/ Global products.

Officer, Regulatory Affairs :
Nov 2004–May 2006
CIPLA LTD- Mumbai
** Handled registration of finished formulations for African Countries[Burkina Faso, Burundi, Cameroon, Dominican Republic, Ethiopia , Ghana, Ivory Coast , Kenya, Mali, Nigeria]; American Countries [Venezuela]; Asian Countries [Myanmar, Srilanka]
** Handled Tenders for Benin, Congo, Cameroon, Ghana, Mali, Sudan, Senegal, Rwanda, Zimbabwe and Zambia-Canada Tender
** Directly dealt with different parties, mailing required documents to them and solving related problems.
** Maintained Track records all the approval received and applications made to respective Regulatory authorities.
** Handled Export Orders for Ghana
** Creation / Updation of packaging materials including Package inserts.

Junior Chemist :
June 2004–Nov 2004
CHEMO TEST LABS PVT LTD- Mumbai
** Conducted chemical analysis of Raw Materials (4 Nos/ day) and Finished Formulations (2 Nos/ day) as per Pharmacopoeial standards / Methods as provided by Pharmaceutical Clients like Cipla, Wanbury, and Pfizer etc.

KEY ACHIEVEMENTS /RECOGNITIONS :
** Registration of Finished Pharmaceutical Products in Bhutan (2 No), Burkina Faso (15 Nos), Kenya (2 Nos), Nigeria (11 No), Senegal (2 Nos), Srilanka (4 Nos) and 1 pharmaceutical finished product in Zimbabwe.
** Transition of Marketing Authorization, Registration and Import Licence for Fertility (8 Nos), NDD and Endocrinological (4 Nos) products from Serum Institute of India to Merck India.
** On-time development of packaging as per Indian regulations to facilitate timely launch in India.
** Registration of 16 cosmetic products in India.
** Clearance of approvals for Food supplements (2 Nos) from FSSAI, India
** Procured Marketing Approval and Registration for 1 Global Vaccine.
** Procured Marketing Approval for locally manufactured Fixed Dose Combinations (5 Nos) in India.
** Procured CT NOC for 3 Fixed Dose Combination , 1 Vaccine and 2 Biological Product for conducting Clinical Trial in India
** Faced 2 Regulatory and Drug Safety Audits (Internal Compliance Review).
** Obtained Post Approval Variation approval for 1 Vaccine and 4 Biological Products.
** Timely submission of Safety Update Reports, Adverse event reports and Clinical Study Reports to DCG(I).
** Was facilitated with an Outstanding Performance Award in Wockhardt for contribution in successful registration of cosmetics in India.

EDUCATION& TRAINING :
PG Diploma in Marketing International Business
Balaji Institute of Modern Management, Pune
Correspondence Course May.
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2008 Bachelor Of Pharmacy Pune University May.2004

RelevantTrainingCourses :
** Training on ‘Trackwise’ system at Merck Serono, Geneva May.2009
** Seminar on ‘Pharmacovigilance’ by Indian Drug Manufacturer’s Association (Medical Committee) July.2009
** Workshop on ‘SOP Development and Management’ July.2009
** Workshop on Impactful Communication Dec.2013
** Workshop on “Mind Mapping and Speed Reading Feb.2014
** Training on Manager Fundamentals Aug. 2014
** Training on Time Management July. 2014

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