1. CURRICULUM VITAE`
Name
Address
Telephone
Email
Dr. Meena K. Thakkar
408, Rajesh park, Kedarmal Road, Malad (E),
Mumbai-97.
+91 22 28836057 / +91 9819422321
drmkthakkar@yahoo.com
Date of Birth
Sex
Marital Status
Nationality
16/5/78
Female
Single
Indian
Registration number: 33420
Educational Qualifications:
Year Board/University Class
March 2001-02
Nov 2000
March 1995
March 1993
Internship
Bachelor of Homoeopathic Medicine and Surgery, Mumbai University.
HSC Bombay Board, Mumbai
SSC Bombay Board, Mumbai
II Class
I Class
I Class
Overall Summary:
 Total of 14+ years of experience in medical industry. This includes 10 years of
experience in Drug safety and Pharmacovigilance and around 4 years of clinical
practice.
Achievements
 Quality: PV CAPA Manager.
 Have been in S.Korea - Seoul for 1.3 yrs. and coordinating with different regional and
Global managers or partner companies for CAPA management activities...e.g.: Japan,
Korea, China, Australia, Taiwan, Indonesia, Hong-Kong, Germany, USA, UK...etc.
 Subject Matter Expert: Responsible for providing domain consultation on PV subjects.
 Have the ability to develop and implement various strategies that support
Pharmacovigilance process improvement of the organization using tools like SPS
(structured problem solving), FMEA and Lean Six sigma green belt.
 Attended workshop for process improvement conducted in UK.
 Well versed with safety databases: Aris G, AER database, SBI and Basecon.
 Working knowledge of MedDRA
 Certification: APMG International - Prince 2 foundation course (Project management)
and Lean Six sigma green belt.
Employment History
May, 2015 till date.
Organization Tata Consultancy Services Pvt Ltd.
Designation Assistant Manager (PV CAPA manager for Japanese Client)
Work Exposure
 Collaborate with Otsuka departments/teams internal and external service providers/
partners to provide oversight and ensure proper development of CAPAs from internal
quality audits and support regulatory inspections as assigned by Associate Director PV
Audit and Inspection Readiness or delegate.
 Support the Otsuka Main Contact (OMC) responsible for the development of responses
to Audit, Regulatory Inspection or Process Deviation observations.

2.  Set up and coordinate the required meetings on behalf of the OMC in order to expedite
the CAPA preparation and closure process.
 Have the ability to communicate ideas clearly and concisely as well as facilitate
meetings at all levels of the organization. Provide management with updates on CAPA
status and produce CAPA metrics for Quality Committee
 Contribute to Global PV CAPA Management implementation and documentation by
completing all required processes, including but not limited to, the following:
o Conduct Root Cause Analysis
o Write Corrective and Preventive Action Plans
o Obtain evidence of CAPA completion
o Track and monitor CAPAs with assigned stakeholders
o Ensure CAPA effectiveness checks, where applicable
o Ensure timely and effective closure of CAPAs and findings
o Attend Global and Regional PV meetings
o Serve as the point of contact for assigned CAPAs.
 Review and revise PVAs and SOPs as per regulatory requirements and company
policies.
 Review and provide inputs in the PV modules prepared for training purpose.
April, 2009 till April 2015.
Organization Tata Consultancy Services Pvt Ltd.
Designation Assistant Manager.
Work Exposure
 Have ability to develop and implement various strategies that support
Pharmacovigilance process improvement of the organization using tools like SPS
(structured problem solving), FMEA and Lean Six sigma green belt.
 Attended workshop for process improvement conducted in UK.
 Working as Subject Matter Expert: Responsible for providing domain consultation on
PV subjects.
 Proactively identifying trends in compliance and proposing solutions to case processing
and resourcing issues.
 Accountable for proactive workload management within their teams and across the
function to ensure that internal and regulatory timelines are met.
 Responsible for providing clear and concise communication to the function regarding
changes and updates to caseload.
 Ensuring compliance to SOPs and other process related documentation across the
function.
 Ensuring that special coaching or training is provided on any topic required/ requested
to ensure that the individuals are appropriately trained for their role.
 Providing technical expertise to the Drug Safety team and mentor/train Drug Safety
Team on ongoing basis in day-to-day activities of Pharmacovigilance projects.
 Well versed with safety databases: Aris G and AER database.
 Establishing and implementing best practice sharing. Ensuring individuals within the
Drug Safety team are audit and inspection ready.
 Reporting of serious adverse events (MHRA, spontaneous, clinical trial cases)
experienced by the patients with associated documentation, tracking systems and data
entry.
Aug, 2008 till March 2009.
Organization Sciformix Technologies Pvt Ltd.
Designation Process Associate.
Work Exposure
 Execute drug safety data management processes – peer review (QC), medical coding,
seriousness assessment, safety narrative writing, expectedness and causality
assessment.
 Quality Analysis of the cases already submitted to the concerned RA. (MHRA,
spontaneous, clinical trials and literature cases).

3.  Perform any other support activities as assigned - tracking various types of information
and metrics, ongoing QC of defined process steps, training, reconciliation of data from
multiple sources including literature search.
 Assume responsibility for quality of data processed.
June, 2006 till Aug, 2008.
Organization Goldshield Pharmaceuticals Pvt. Ltd.
Designation Executive – Medical Affairs.
Work Exposure
 Drug Safety.
 Regulatory Support.
 Medico-marketing Services.
 Independently handled the “Internal Audit” conducted for PV & DS in May 2008.
 Prepare, conduct and assess Pharmacovigilance trainings for all the associates.
 Risk Management: Writing “Dear Doctor Letter” for the concerned actives.
Writing “Caution-in-use” notification for the concerned actives.
 Actively support the pharmacovigilance activities and risk management plans
recommended and/or finalized by the Company.
 Medically reviewing PSURs for UK/Irish/European market.
 Review and Updating the SOPs required for running the Medical information, Medico
marketing and Drug safety operation.
 To prepare, review & update SPC’s and PIL’s for Company’s pharmaceutical products
 Harmonize SPC/PIL for different countries (e.g. UK/Ireland), as per the regulatory
requirements/variation.
 Update PIL for user testing under the guidance of Head Medical Affairs and offer
necessary assistance to the business units during user testing.
 MHRA/EMEA updates: To review Safety updates for medicinal products for human use
on a weekly basis.
 Execute drug safety data management for ASPRs (Anonymised single patient reports)
received from UK (a combination of case entry, medical coding, seriousness
assessment, safety narrative writing, peer review and causality assessment) into
database on regular basis.
 Resolving and responding the safety related queries raised by the RAs
 To generate signals for the concerned molecule.
 Monitoring & reporting safety of Goldshield Group’s pharmaceutical products, to meet
global regulatory requirements.
 Prepare, conduct and assess trainings for the all the associates on Medical and
Regulatory issues.
 To review published medical literature, medical databases & conduct online information
search to buildup in-house database / supporting literature on Company’s products.
 Responsible for providing medical information services on Goldshield’s range of
products to consumers, healthcare providers and other external and internal
customers.
 Responsible for approving Promotional material for Healthcare products.
 Prepare and update abbreviated prescribing information, whenever necessary and
appropriate.
 Provide updated information about the company products to Irish medical board to be
inserted in MIMS Ireland.
 Support the pharmacovigilance partner/teams to ensure that company continues to get
the quality service from the vendor.
September, 2001 till June 2006.
Organization Anand clinic.
Designation Assistant Doctor.
Work Exposure
 Taking case history of patients.
 Working out possible remedies for illness.
 Locum twice in a year.

4.  Submitting articles on case taking.
August, 2002 till June, 2006.
Organization Health care for children.
Designation Assistant Doctor for children care.
Work Exposure
 Advising patient's parents telephonically.
 Taking case history of the patients.
 Giving dietary advice to the parents.
February, 2003 – July, 2003.
Organization Shruti Clinic
Designation Residential Medical Officer (RMO).
Work Exposure
 Taking case history of patients.
 Differential diagnosis of the disease.
 Providing medicinal advice.
April, 2002 - August, 2002
Organization Sanjeevani Hospital.
Designation Residential Medical Officer (RMO).
Work Exposure
 Admission of patients.
 Care of patients in the wards including a daily ward round.
 Attend Specialist Medical Officer ward rounds and record all decisions made in the medical
history.
 Ensure that consultations occur when requested.
 Accurate and timely recording of drugs and treatment.
 Checking and signing of result sheets for investigations.
 Accurate and comprehensive recording in the medical record including progress notes each
day.
 Discharge planning.
Hobbies & Interests
 Music, reading books, cooking.