Pharmacovigilance executive

DR. MANJIRI NIRGUDKAR.

Career Objective:

With my extensive experience and education, seeking an opportunity in Clinical research, life sciences and healthcare as a confident Pharma and Quality assurance player.

Education:

• Bachelor of Homeopathic medicine and surgery - BHMS and an internship from Y.M.T Homeopathic medical college (Navi Mumbai, India) in Feb-07.

• Post graduate diploma in Clinical Research from CREMA (CLINICAL RESEARCH EDUCATION AND MANAGEMENT ACADEMY, MUMBAI, INDIA) in Dec-2008.

Work Experience:

Total experience –5 Years.

TATA CONSULTANCY SERVICES (Mumbai, India)

Jan-10 to March-12

Role: Quality representative (Quality Assurance) Pharma and life sciences

Responsibilities:

To handle quality issues and compliance of Pharmacovigilance, data management, clinical programming, medical writing and clinical document management and submissions.

• Application of Six sigma tools, LEAN tools and root cause analysis for process improvement and value add activities.

• Conducting quality and process improvement trainings.

• Reviewing mandatory process related documents and approve them.

• Maintaining Quality standards (ISO and CMMI) by facilitating the operations across the domain.

• To work closely with operations managers regarding client issues and requirements. To have a detailed look on client feedbacks and survey scores and take prompt and appropriate action regarding negative comments as well as improvement opportunities.

• To help processes for Audit preparations according to ISO and ICH-GCP standards.

• To conduct internal audits across organization/domain on a quarterly basis.

• Submission of audit report and analysis of audit findings.

TATA CONSULTANCY SERVICES

Dec-08 to Dec-09

Role: Drug safety specialist and quality review and control for PHARMA domain (Pharmacovigilance)

Responsibilities:

• Quality check for all processed cases in drug safety.

• Quality check of the patient illness (Hospital, progress, OPD) records for Medico-legal cases.

• Case processing

• Signal detection

• Case Triage, medical coding, data entry, PSUR and narrative writing.

• Error reporting and mentoring the associates for better quality of the deliverable.

• Audit preparation and participation. (Attended and faced FDA and several client audits)

• Root cause analysis and CAPA ( Corrective And Preventive Action) for all errors occurred as well as audit findings.

• Mentoring and training the associates regarding knowledge of Medical coding (MedDRA) and FDA rules and regulations regarding Pharmacovigilance and adverse event reporting.

• Conducting trainings regarding clinical research for new joiners (domain and process training).

CALIBER POINT BUSINESS SOLUTIONS (Navi Mumbai, India)

Mar-08 to Dec 08

Role: Senior service delivery executive.

Responsibilities:

Handling a market of Australia and New Zealand for newly marketed drugs and devices and their side effects.

• Quality lead for Post marketing surveillance trials for all the drugs in the market.

• Analysis of side effects and interpretation of doctor’s comments regarding various drugs used by them in their daily practice (Pharmacovigilance).

• To make a consolidated report for marketing companies according to the negative as well as positive points mentioned by practitioners regarding new drugs in market with region wise statistical report on a monthly basis.

• Communicating with client regarding new updates and errors.

• Training and mentoring associates regarding updates in Pharma industry and medical knowledge.

• Implementing several changes in the process for Process Improvement and Quality enrichment.

DMRI (drug monitoring and research institute,Mumbai)

Feb-07 to Mar 08

Role: Clinical research coordinator/ Clinical monitor (Intern and employee)

Responsibilities:

Trial site visits for reviewing and compliance of clinical documents (IB, protocols and CSRs)

• Preparing and reviewing protocols for BA/BE studies, phase two and phase three studies.

• Regulatory affairs and advice if any aspect of trial is not according to the guidelines (E6) and protocol.

• Quality control.

• Audit preparations.

• Preparing SOPs

• Screening, general examination and monitoring of trial subjects.

• Worked under an Investigator for Phase three trials.

CHANDRAGANGA HOSPITAL (Mumbai)

Jun-06 to Jan-07

Role: Residential Medical officer.

CERTIFICATIONS, AWARDS AND TRAININGS:

• Certified Internal auditor (Tata Consultancy Services)

• Certified for Root cause analysis

• Structured problem solving

• LEAN trained.

• Six sigma Green belt trained

• Advanced excel.

• ICH-GCP trained.

• MS-CIT certified (Basic education and certification for MS office, excel and powerpoint)

• Awarded for several medical camps conducted and participated in Mumbai floods in July 05.

• Elementary drawing examination certified.

• Many certificates in sports, essay writing, dance and music.

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