RESUME

To be a part of a progressive organization to pursue a career in Clinical Research, which provides me sufficient opportunities to implement my knowledge and enhance my abilities.

Period: Since 11 October 2010

Organization: AstraZeneca India Pvt. Ltd, Bangalore, India

Designation: Medical and safety physician

Scope: To be the global safety physician and manage all the medical and safety aspects of the assigned products and also manage the scientists responsible for these products in ensuring that the safety and efficacy of the product is adequately reviewed

Job Responsibilities:

• Provide medical expertise and judgment to ensure ongoing evaluation of overall safety and efficacy profile for assigned products, including review of changes to reference safety documents, changes to originator labels in relevant countries, review of cumulative case listings and signal detection for assigned products supporting assigned scientists.

• Accountable for benefit-risk assessment of assigned products

• Key member of the PERM team, using medical expertise and knowledge of disease area and product profile to provide strategic advice to ongoing portfolio review process

• Provide strategic input to Branded Generics portfolio review process using medical knowledge of disease area and product profiles to facilitate decision making.

• Provide medical expertise for production of regulatory requirements such as periodic report production/review or production of responses to Health Authority queries

• Provide medical expertise and judgment to support the case-handling process with medical review of individual cases and for assigned products

• Provide Patient Safety medical expertise and judgment in the production and maintenance of global Patient Risk Management Plans for assigned products if required by an authority or identified to require one by internal AZ assessment

• Maintain knowledge of relevant disease and therapeutic areas for the branded generic drugs, in order to support Due Diligence process and ongoing surveillance post launch.

• Gain knowledge of the pharmaceutical generic business and build a network within this area

• Ensure compliance with relevant procedural documents

• Provide Strategic input into Regulatory Authority submissions, queries and discussions with high level of attention to implications in all relevant countries for the product including essential wording for AZ labels for that product.

• Acquire knowledge of safety reporting requirements of the EU states and relevant knowledge of other countries where assigned products are marketed

• Establish and maintain good communication channels with the EU QPPV, Marketing Companies and other teams within the BGx hub

• Support a performance-driven culture

Period: From 24 February 2010 to 08 October 2010

Organization: Bluefish Pharmaceuticals Pvt. Ltd, Bangalore, India

Designation: Senior executive – Pharmacovigilance (Medical)

Scope:

• Manage and train junior people within Corporate Pharmacovigilance department at Bangalore office

• Maintain and develop Corporate Pharmacovigilance activities as per EU requirements.

• Assist QPPV/Deputy QPPV in Europe for the Safety activities of the company products

Job Responsibilities:

• Processing spontaneous and literature cases (i.e. triage-assessment, data entry; write narrative, MedDRA coding, medical assessment and reporting to authorities).

• Processing SDE cases with partners; compile reconciliation reports

• Quality review of safety data entered in the Global Safety Database

• Signal detection and preparation of reconciliation reports for review

• Compile data for PSUR including line-listing and summary tabulations, write PSUR and submit to authorities.

• Prepare response to authority queries and PSUR assessment reports

• Assist in preparation/update SOP

• Maintain PV archive (electronically & hard copy) updated

• Prepare training material and perform training

Period: From 15 January 2007 to 18 February 2010

Organization: Accenture Services Pvt Ltd, Bangalore, India

Designation: Team lead, Medical research support team

Job Responsibilities:

Medical Affairs

• Review of study protocol, CRF and integrated data review plan (IDRP)

• Assist in analysis and medical review of safety and efficacy data arising from all phases of clinical trials

• Assist in the resolution and response to safety Issues or queries

• Medical review of trial data

• Coding of events by using MedDRA and drugs by WHO-DD

People management

• Objective setting

• Regular performance assessment and

• Feedback

Project management

• Work allocation

• Quality check

• Training

• Ensuring all the deliverables to the client are consistent and meet the service level agreement requirements

• Preparing the metrics data and share with the clients in a timely manner

• Process improvement initiatives

• Estimete the work forecast and hire new people accordingly

Period: From 01 August 2006 to 31 December 2006

Organization: American Medical Education Resource Institute, Bangalore, India

.

Designation: Assistant professor

Job Responsibilities:

Impart training in immunology & physical diagnosis

Period: From 08 Jan 2004 to 31 Mar 2006

Organization: National Leprosy Eradication Programme, Bangalore, India

Designation: District leprosy adviser (medical) - District technical support team

Job Responsibilities:

Operational management and supervision of the National Leprosy Eradication Programme at district level

Develop and sustain initiatives to ensure the programme is adequately run as per NLEP guidelines

Prepare and report programme statistics and thus measure the efficiency of the programme and also initiate preventive and corrective measures

Medical supervision of the trials of UNIFORM - MULTI DRUG THERAPY (MDT) regimen for leprosy treatment

Period: From 07 October 2003 to 07 January 2004

Organization: Hutti Gold Mines Hospital, Hutti, Karnataka, India

Designation: Medical officer

Job Responsibilities:

Medical care of the mine employees

Period: From 08 November 2001 to 06 October 2003

Organization: Army College of Dental Sciences, Secunderabad, India

Designation: Lecturer

Job Responsibilities:

Impart training in anatomy and pharmacology

Period: From 01 July 2000 to 31 October 2001

Organization: Gokul Maternity and Nursing Home, Raichur, Karnataka, India

Designation: Duty doctor

Job Responsibilities:

Medical care of patients in the hospital

• Won ‘Numero Uno’ award in Accenture for the month of September-2007, which recognizes high performance for that month

• Presented a paper on the “epidemiological aspects of leprosy in the two districts of Karnataka” during the biennial conference of Indian association of leprologists at Agra, India on 13 Nov 2005.

• Was sent to the client location onshore in USA for higher training from 03 to 31 Oct 2008..

• ICH-GCP guidelines

• New drug development process

• International pharma - regulatory guidelines

• Ethical issues in clinical research

• Overview of Pharmacovigilance

• Basic understanding of PSURs

• Case processing in Pharmacovigilance Database

• Overview of MedDRA

Computer proficiency:

• MS office (MS word, MS excel, MS powerpoint), Internet surfing

Database proficiency:

• Hands-on experience on the different databases and tools worked so far

• Biennial conference of Indian association of leprologists at Agra, India from 11- 13 Nov 2005

NAME : Dr. Ramesh V Pandherpur

FATHER’S NAME : Mr. Venkobachar Pandherpur

DATE OF BIRTH : 08 July 1977

SEX : Male

NATIONALITY : Indian

PRESENT ADDRESS : No.2/1, Ground floor,

Gowlani Apartments, 2nd cross,

Thayappanahalli

4th T block, Jayanagar,

Bangalore - 560041.

CONTACT NUMBER : +91-988*******

E-MAIL : qlmj6h@r.postjobfree.com, qlmj6h@r.postjobfree.com

Examination University/

Institution Year Of completion

Bachelor of medicine and surgery (MBBS) Vijaynagar institute of medical sciences, Bellary, Karnataka, India 1999

Post graduate diploma in clinical research Institute of clinical research India, Bangalore 2007

Place: Bangalore, India Dr Ramesh V Pandherpur

Contact this candidate