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Pharmacovigilance Resume Sample, Experience : 13 years

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Name of the Candidate:[Private]
Name of the Post Applied:Pharmacovigilance
Job related skills / software:Knowledge of clinical trials, Cosemetology and dermatology studies and BA/BE studies, Knowledge of monitoring and auditing procedures, Knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements.
Category:Medical
Sub Category:Pharmacovigilance
Years of Experience:13 years
State:Maharashtra
Gender:Female
Salary Expected per Month(Rs):40,000 to 50,000
Highest Qualification attained:Diploma
Major / Specialization:Clinical Research
Email Id:[Private]
 
Are you looking for job now?:Yes
Can the recruiter contact you?:Yes
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Summary of Qualifications  :
Education  :
Professional diploma in clinical research from Catalyst service Pvt Ltd  :Delhi Unversity (Distance course – from July2009-December 2009)
Diploma in General nursing and midwifery from Sir Harkisondas Hospital. Mumbai University(Full time Course from 1993-1996)

Skills  :
Knowledge of clinical trials,cosemetology and dermatology studies and BA/BE studies.
Knowledge of monitoring and auditing procedures.
Knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements.
Contribution in SOP and system development
Good Understanding and knowledge of S.O.P.'s for System and process.
Able to work effectively and efficiently in a matrix environment.
Strong knowledge of Windows, Word and Excel based operating systems, software applications.
Quick study, with an ability to easily grasp and put into application new ideas, concepts, methods and technologies. Dedicated, innovative and self-motivated team player and builder.
Able to work under optimal supervision
Excellent organization, planning and problem solving abilities.
Excellent negotiation and analytical skills.
Established interpersonal and communication skills.
Fluent in English and other local office languages both verbal and written.
Proficiency in computer.

Employment Summary in brief  :
More than Eleven year of clinical research experience (Phase II, IV) as an Assistant Project Manager, Sr. Clinical research associates, Sr. Clinical Co-ordinator and Nurse.
Both Sponsor and CRO experience
Working knowledge of Good Clinical Practices.
Excellent written and verbal communication skills.
Ensures Serious Adverse Event (SAE)/Adverse event(AE) reporting according to project specifications, reviews SAE information, resolves queries and assists sites in completion of SAE/AE reports.
Responsible for accurate and timely data collection, documentation, entry, and reporting.
Therapeutic experience includes

As Assistant Project Manager  : Tinea Versicolor (Dermatology), Sexual Dysfunction, Lumbago, Integumental pain and Musculo-skeletal pain, Osteoarthritis of the Knee Joint, Stage 2 Mild hypertension, Chronic Rhinitis, Amoxicillin (Bioequivalence and Bioavailability study) ,Gout and stemcell.

As Clinical research project Executive  : bioavailability study curcumin, Hair growth retarding formulation, allergic rhinitis

Appreciations  :
1. Certificate of appreciation in Vedic Life sciences Pvt. Ltd for overall contribution in the system development.
2. Certificate of appreciation letter for the extraordinatory contribution towards business development activity

Certifications/Training :
1. 2010-One day workshop conducted by ISCR on clinical research and Quality in Mumbai on 10th of April
2. 2010-One day Training Conducted by Synergetic training solution Mumbai on 20th of March.” Moving from Site Monitoring to site Management for the Next Generation CRAs”
3. 2009- Two days training program arranged by CREMA Mumbai on 7th and 8th of August “Advance GCP-Theory to Practice”
4. 2008- AICTE sponsored national seminar on “Recent trends in clinical Research and project Management” at Dr. L.H. Hiranandani College Of pharmacy (Ulhasnagar) Mumbai
5. 2008- GCP Quiz at arranged by ACEBIOMED Pvt Ltd.
6. 2006- Two days seminar organized by IDMA in collaboration with CDSCO on clinical trial at Mayfair (Worli) Mumbai (Topics covered, Project management, Role of Sponsor and Investigator, Protocol designing, ADR, Statistics)

Pharmacovigilance experience  :
Lead the training and mentoring of internal and cross-functional team members on Handling ,reporting and recoding of AE/SAE on the base of protocol ,IB and Literature search (Clinical operation, site staff, Quality assurance and data management
2. Provide input into responses to inquiries from regulatory authorities or Ethics committee and sponsor on safety issues
3. Assist in the development and updates concerning safety input to the core data sheet and the investigator’s brochure(Project specific)
4. Play an active role in standing and Safety Management Team (SMT) meetings(As required Project specific)
5. Interfaces with the clinical team for safety matters including follow-up on events of interest and input into site queries regarding adverse events.
6. Provide clinical input to detailed review of events of interest for key data extraction for analysis purposes including the PSUR to report writing team
7. Assist in the preparation of other safety documents, as required, including the Annual Safety Update Report (ASR) and the Investigator’s Brochure (IB)
8. Participates in review of clinical study protocols /reports/other regulatory documents as needed.
9. Provides support as required for licensing activities, regulatory authority inspections/audits and for project/product recall activities.
10. Generation and review of SOPs and Work Instructions
11. Monitor the quality of work produced by the team and train & mentor new & existing team members
12. Management of Compliance with the Company(CRO/Sponsor) Standard Operating Procedures and regulatory requirements
13. Link effectively and maintain excellent relationship with the clients and internal/external contacts.
14. Analyzing, Evaluating of AE/SAE and raising DCfs ,resolution of Dcfs, Completion of data, Reporting to Ethics committee, regulatory and sponsor
15. Knowledge of Medical terminology

Employment Summary in detail  :
1. Vedic Lifesciences Private Limited (March 2009 –April-2013)

Position held  : Asst. Project Manager (from 1st April 2010-April-2013)
Managed CROs and other vendors.
Developed budgets, metrics and timelines.
Provided strategic input to increase enrolment and meet timelines.
Developed processes, metrics, protocols, and study tools.
Negotiated contracts and selected vendors.
SOP review and development.
Ensured site personnel were following good clinical practices (GCPs).
Verified site personnel were adequately consenting subjects with proper informed consent documents.
Reviewed site standard operating procedures (SOPs).
Reviewing of Essential documents as CRF, ICF and safety reports
Ensuring the implementation of project plans as assigned.
Responsible for site monitoring, site management, site administration and registry management for clinical studies according to GCP, ICH Guidelines, and Company Standard Operating Procedures.

Position held  : Sr.Clinical Research Project Executive (Sr.CRPE) (from March 2009- till 1st April 2010)
Performed in-house source document verification.
Reviewed Case Report Forms to ensure adherence to protocol specific guidelines per client.
Trained team members on study protocol, source document and review
Represented both data management and the clinical department at team meetings to determine study timelines.
Re-assessed resourcing needs on an ongoing basis.
Trained investigator sites on study protocol, data recording and reporting.
Compiled patient eligibility listings and exemptions for Client.
Performed site qualification, initiation and monitoring visits for a post-marketing study.
Coordinated study start-up activities including site selection and qualification and data management functions.
Reviewed in-house Ethics committee documents to ensure quality control.
Data collection and quality control of data collected.
Ensured compliance with protocol, SOPs, and GCP/ICH guidelines.
On-site query resolution and verification.
Performed drug accountability and disposition.

2.
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ACE BIOMED (P) LTD. – INDIA
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Position held  : Sr. Clinical Co-ordinator (from Nov 2004 – till Nov-2008)
Participated in different design/ types of studies e. g Steady state, Inhaler studies, Ointment, phase II and III
Preparation of standard operating procedure, implementation.
Performs Screening, study initiation, monitoring, and conduction.
Attending site selection, before, during and close out meeting of study.
Conduction of protocol meeting.
Review of protocol and report (clinical)
Preparation of essential documents.
Manages the progress of assigned studies by CRF completion and data query generation and resolution.
Creates and maintains appropriate documentation regarding study monitoring findings and action plans by submitting reports and other required study documentation
Delegation of duties to CRA and other clinical staff.
Initial, up gradation and continuous training of clinical staff.
Responsible for clinical equipment for the calibration, getting regular maintenance done.
External communication for study purpose.
Vendor audit prior and during study (Catering, Pathology, hospital.)
Emergency medical care, Handling ADE, ADR
Training and assistance to junior clinical staff .
Arranging quiz on SOP and discussion on GCP various topics and actively participating.
Attended audit by Envisa, NABL, EMEA for study and site approval purpose
Independently conducting study except protocol and report preparation.

3. MEDLAR LABORATORIES PVT LTD. – INDIA :
Position held  : Head Clinical Nurse ( from 2001 – till 2004)
Independent handling of Phlebotomy by arranging Phlebotomists on Contract & giving them training about blood collection.
Maintaining Volunteer bank in Software.
Helping physician For Screening.
Taking E.C.G., Blood collection by Vacutainers or Syringe/needle
Supervising & Guiding Phlebotomists during Study Blood collection.
Custodian duty for Volunteer during Study.
Keeping Records for Volunteer Linen, Accessories Used for Bioequivalence Study.
Drug Administration to Volunteers.
Maintaining Crash cart Trolley, Defibrillator, Nebulisation Machine, Oxygen Cylinder.
Putting Veinflon for study Blood collection, Attending Ambulatory Visit.
Centrifuging Blood Samples, Plasma Separation, Marinating Volunteer plasma Samples in Deep freezer under required Storage Condition.
Attended audit for ENVISA, WHO, Brazil.

4. WELLQUEST CONTRACT RESEARCH ORGANIZATION – INDIA :
Position held  : Clinical Nurse (1999 – 2001)
Helping physician For Screening.
Maintaining Volunteer bank in Software
Taking E.C.G., Blood collection by Vacutainers or Syringe & Needle.
Supervising & Guiding Phlebotomists during Study Blood collection.
Custodian duty for Volunteer during Study.
Keeping Records for Volunteer Linen, Accessories Used for Bioequivalence Study.
Drug Administration to Volunteers.
Maintaining Crash cart Trolley, Defibrillator, Nebulisation Machine, Oxygen Cylinder.
Blood collection, Attending Ambulatory Visit.
Centrifuging Blood Samples, Plasma Separation, Marinating Volunteer plasma Samples in Deep freezer under required Storage Condition.

5. Bhatia General Hospital :
Position held  : Staff Nurse (1996 – 1999)
Experience in 20 beds Medical & Surgical unit.
Handled Medical Cases like Ischemia, Myocardial Infection, Angina, and Peritoneal Dialysis.
Surgical cases Neurology, Nephrology, Gastrointestinal, Orthopedic, and Pulmonary Diseases. Attended Procedures Pacemaker, Intubation, Resuscitation.
Handling Independently Ventilator Newport wave, Breeze, Dragger.
Specialization in physiotherapy, care of Bed ridden Patient, Patient with Endotraceal tube (oral or Nasal)

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