Resume CV : Pharmacovigilance, Regulatory Affairs, clinical research

[sridh]

vemula sridhar reddy
Email : vemula.sridharreddy AT gmail.com

OBJECTIVE :
To pursue a challenging career in the area of Pharmacovigilance/Clinical Research and to become a part of esteemed organization that gives me scope to enhance my knowledge and skills, which results in my personal and professional growth.

EDUCATION :
- Master of Pharmacy in Pharmacy Practice from J.S.S University, Mysore.
- Bachelor of Pharmacy in Pharmacy from Kakatiya University, Warangal.

WORK EXPERIENCE :
Aug 2010 to till date Clinical Research Associate Shantha Biotechnics (Part of the sanofi – aventis Group), Hyderabad.
July 2010 to Aug 2010 Associate Professor St.Peter’s College of Pharmacy, Warangal.
Feb 2009 to Jun 2010 Clinical Research Coordinator JSS Hospital, Mysore.

PROFESSIONAL EXPERIENCE :
ROLES AND RESPONSIBILITIES AS A CLINICAL RESEARCH ASSOCIATE :
SHANTHA BIOTECHNICS (Part of the Sanofi – Aventis Group), HYDERABAD.
- To provide assistance, where directed by the Project Manager, in specific tasks relating to the preparation of the project
- Assist with preparation of required regulatory submissions
- Assist clinical sites with IRB/IEC submissions and ensure collection of required Essential Documents for study start-up and throughout conduct of study as per ICH-GCP E6 guidelines
- To prepare all practical arrangements (e.g. budgets supplies, etc.) for approval by line management
- To assist with the design of CRF’s as agreed within the project team
- To ensure all personnel at study sites are appropriately informed and trained. This will include

Information and training on :
- Protocol – including any special efficiency or safety measurements
- AE reporting
- Case record forms, Patient information sheets and informed consent
-Ethical Committee requirements
- Supplies presentation, storage and accountability
- Biological sample preparation, storage and transportation
- Requirements of Good Clinical Practice
- To develop any necessary aids to allow studies to proceed expeditiously (e.g. newsletter, investigator flow charts)
- To maintain awareness of local regulatory requirements, and to conduct studies in accordance with Shantha SOPs, guidelines and ICH Good Clinical Practice guidelines
- To make regular contact with investigators or other site staff members during the course of studies, to ensure all is proceeding to agreed protocols and time schedules, and that the data is
being recorded accurately and returned to Shantha to required timescales
- Perform monitoring visits according to monitoring plan

OTHER CERTIFICATIONS and TRAININGS :
- Post Diploma Certificate Course in “Clinical Research” from Catalyst Clinical Pvt. Ltd, Delhi.

MEETINGS & SEMINARS :
- Attended ‘INVESTIGATOR MEETING’ for phase III Clinical trial at New Delhi in July 2009
- Attended Indian Pharmaceutical Congress (December, 2005) held at Hyderabad.

TECHNICAL SKILLS :
- Successfully completed training in GCP and EDC conducted by Sponsor.
- Participated in sponsor’s Audit
- Good Working knowledge on different Clinical data bases like Phase Forward, Oracle, and Clinphone.
- Good Working knowledge with IVRS and IWRS systems.
- MS office (Word, Excel and PowerPoint)

CORE COMPETENCIES :
- Historical Background - Nuremberg code, Kefauver – Harris Amendments, Declaration Of Helsinki, and Belmont Report etc
- ICH -GCP guidelines and FDA regulations
- INDIAN – GCP and ICMR guidelines
- DCGI, IBSC, RCGM and GEAC
- Schedule Y, Drugs and Cosmetics Act and Regulatory bodies in India
- Drug Discovery and Development, Preclinical trials, IND (Investigational New Drug application), NDA (New Drug Application) and Phase I to Phase IV studies
- Project management in clinical trials, Audits, FDA Inspections and Quality assurance

PERSONAL SKILLS :
- Excellent verbal and written communication skills.
- Ability to lead the team and willingness to learn.
- Capable to work Independently, and manage stress, time and people effectively
- Have Problem solving ability,
- Ready to relocate and work at flexible timings.

DECLARATION :
I hereby declare that all the information given above is true to the best of my knowledge.

Date :

SRIDHAR.V

[Guest]

Tilak
E-mail : sri5til AT gmail.com

Objective :
Pharmacist with 9 years of experience in Hospital, Clinical, Retail & Regulatory Affairs setting in Australia & India looking for Business Analyst / Implementation or Delivery Consultant position in Healthcare IT space involving EHR, EMR, Electronic Medication Management & E- Prescribing.

Summary :
- An adept professional & SME with 6 years of opulent experience as Pharmacist & Healthcare Professional in Australian Hospital Setting & 1.5 years of experience in the Retail Setting. Also experienced in Indian Pharmaceutical industry for 1 year & 9 months in Regulatory Affairs & Marketing and Sales.
- Sound knowledge of operating Hospital Pharmacy Software Solutions like I.Pharmacy & Ascribe used in Australia, New Zealand & UK. Sound knowledge of Retail Pharmacy Solutions like Winifred, Minfos, and Lockie Dispensing Software in Australia.
- An ardent analyst of the data requirements of stakeholders.
- Good knowledge of using ICD – 10AM coding & the 3M’s software used for coding.
- Sound knowledge of using Laboratory Information Systems such as AUSCARE, AUSLAB used in Australia.
- Good knowledge behind the concepts of implementing Electronic Medical Record (EMR), Electronic Medication Management (EMM).
- Good knowledge behind usage of Nursing Information Management Systems such as Trendcare & The Viewer (Electronic Health Record {EHR}) & Enterprise Medication Liaison System (ELMS){Used for preparing Discharge Medication Record}, used in Queensland Health in Australia.
- Good understanding behind the concept of Software Development Life Cycle (SDLC), Healthcare in United States & HIPPA.
- Intermediate to advance knowledge in Microsoft Office Products such as Office, Excel & PowerPoint.
- Good understanding of concepts behind UML, SNOMED, HL7 & CDA.
- Good understanding of concepts behind Use Case Writing.
- Hard working, Outgoing, Courteous, Friendly Personality, Reliable, Good Natured and an Effective Team Member.

Employment Recitation :
Period : 27th April 2009 – 4th April 2012
Employer : Queensland Health, Queensland, Australia
Role : Clinical & Distribution Pharmacist
Responsibilities :
- Dispensing & distribution as per the Society of Hospital Pharmacy of Australia (SHPA) & Queensland Health guidelines.
- Clinical activities as per the General Level Framework Clinical Pharmacy Guidelines of Queensland Health & SHPA which involved medication history taking, reconciliation, counseling to doctors (with respect to Drug-Drug, Drug – Physiological discrepancies), nurses & patients for optimizing therapeutic outcomes. Preparing discharge medication profile for discharge patients.
- Managed 20 methadone clients as per the Queensland Opioid Therapy Practice Guidelines (QOTP).
- Weekly management of Chemotherapy & Oncology Treatment patients by checking their clinical lab parameters & protocols using EviQ guidelines.
- Involved in Change Management from Non-PBS to PBS Pharmacy in 2010.

Project in Queensland Health :
Performing Business Case Analysis for the Wide Bay District Hospital for the purpose of increasing in Pharmacy Staff in comparison to workload for future.
- Used Microsoft Excel to perform data analysis & produced graphs with the help of data obtained from Decision Support Software such as I.Pharmacy, Script Tracker software, Enterprise Liaison Medication System software.
- It involved data comparison of number of discharges, admissions, number of discharges medication dispensed per pharmacist, number of inpatient medications supplied by each pharmacist, discharge medication record produced by each pharmacist. It also involved comparison of time delay in dispensing of discharge & leave medication of patients.
- This comparison was done in all the 3 hospitals i.e. Maryborough Base Hospital, Hervey Bay Hospital & Bundaberg Base Hospital in Queensland Health.

Accomplishments :
- Designed & implemented a guideline for Nursing Staff regarding the flow of discharge & leave planning process with respect to the medication dispensing which streamlined the dispensing of discharge & leave medication delays from Pharmacy department.
- The data analysis that was performed in the project is going to be used by the Director of Pharmacy for future presentation to the Hospital CEOs & Directors for an increase the staffing of Pharmacy Departments in all the 3 teaching hospital of the district.

Period : 4th March 2006 – 3rd February 2009
Employer : Hospital Pharmacy Services (HPS), Whyalla Hospital & Health Services Inc. Department of Health, Government of
South Australia (SA)
Role : Pharmacist In Charge
Responsibilities :
- Dispensing & Distribution as per the SHPA & SA health guidelines
- Participating in drug recall
- Clinical activities as per the SHPA & SA Health guidelines & chairing of Drugs & Therapeutics committee meetings.

Administrative & Management duties involved :
- Preceptor for 21 final year Australian B.Pharm graduates & one intern. Giving in-services to Nursing staff every month.
- Providing monthly pharmacy finance management report to department heads, hospital CEO & finance department that involved best cost allocation & inventory management with respect to medications in pharmacy & wards.
- Managing staffing issues & performing bi-annual appraisals as per the company’s HR policies.
- Contributing to the quality improvement initiatives of pharmacy department to comply with Australian Council of Healthcare Standards (ACHS) accreditation.

Accomplishments :
- Achieved a score of 4.4 out of 5 consecutively for every 6 months of client survey from HPS to the Hospital with respect to Pharmacy Services from the time I had joined the work, which is above National & State average of all HPS Client Pharmacies involving excellent Customer Service.
- Implemented RUM (Return of Unwanted Medications) project at the Pharmacy Department of Whyalla Hospital & Health Services.
- Prepared Pre-Operative Antibiotic Guidelines for Surgeons at Whyalla Hospital which was passed through the Drugs & Therapeutic Committee meeting & was used by Surgeons at the hospital.
- Modified the Hospital Imprest System, which involved cost minimization for the Pharmacy Budget.
- Revised Hospital Formulary once every year to reduce the cost minimization while purchasing the medications.
- Presented on Cardiac Conditions to Cardiac Rehabilitation Committee, which involved the members of the public questioning the pharmacist about different cardiac conditions & their treatments on different occasions.

Period : 3rd January 2004 – 29th June 2005
Employer : Soul Pattinson Chemist, Palmerston, Northern Territory, Australia
Role : Intern Pharmacist
Responsibilities :
- Dispensing, Distribution & Counseling of patients on Schedule 2,3,4 & 8 medications as per the PBS guidelines
- Preparation of extemporaneous product & responsible for Medicare Claim Program run by Pharmacy

Accomplishments :
- Managed 35 Webster pack patients every week of pharmacy involving preparation of Webster packs and managing their scripts.
- Managed 11 Aboriginal Community Hospitals in and around Darwin & NT in supplying medications through courier under the special Section 100 medications for 3 months under the supervision of Pharmacist.

Period : August 2000 – March 2001
Employer : Orchid Healthcare Limited, Chennai
Role : Executive - Drug Regulatory Affairs
Responsibilities :
- Preparation of Drug Technical Dossiers and documentation using MS – Word, Excel and Power Point products, ICH and WHO guidelines.
- Teamwork involving senior executives, manager, commercial department, R&D of company and Ministry of Health of India.

Accomplishment : Achieved registration for Cefixime (Fifth generation cephalosporin) from Malawi.

Period : January 2000 – August 2000.
Employer : Astra – Zeneca Ltd., Chennai, India
Role : Professional Service Representative
Responsibilities :
- Direct sales of pharmaceutical products to physician and retail chemists.
- Involved teamwork skills, communication skills and change management.
Accomplishment : Achieved record sales of our brand "Stop-IT" (Ciprofloxacin + Tinidazole) in our sales region due to good rapport with doctors leading to more prescriptions being written for our product.

Period : June 1999 – December 2000.
Employer : Saravana Pharmacy, Chennai, India.
Role : Community Pharmacist
Responsibilities :
- This job involved dispensing of medications to patients on physicians prescription & selling OTC medications.
- The job also involved prescription reviewing, inventory control, patient counseling, counseling with Physicians in relation to their prescription.

ACADEMICS :
Master of Health Information Management from University of Sydney, Sydney, Australia.
Subjects Studied : Medical Terminology, Project Management, Management Information Systems, Coding using ICD-10AM, Clinical Data Management, Case mix Management & DRGs & Managing Medical Records.
Graduate Certificate in Information Technology from University of South Australia, Adelaide, Australia.
Subject Studied : Internet & Communication Technology, Mathematics for Computing, Computer Hardware, Basic web designing, Basics of JAVA.
Bachelor of Pharmacy from Tamilnadu Dr.MGR Medical University, Chennai, India

IT Skills :
- Intermediate to advanced Microsoft Office Applications
- Basic Computer Hardware & web designing
- Proficient in using Hospital Pharmacy software programs such as Ascribe, I.Pharmacy & retail pharmacy software programs such as Lockie, Winifred & Minfos.
- Knowledge of using 3M’s ICD – 10AM coding software.
- Good knowledge of using Laboratory Information Systems & Nursing Information Management Systems of Australian Origin.

PROJECT EXPERIENCE IN MASTERS PROGRAM :
- Experienced in working for Sydney Adventist Hospital (SAH) – GP Networking Project {Electronic Discharge Summary (EDS)} in Information Services Department of Sydney Adventist Hospital (SAH), Sydney in 2002.
It involved :
- Performing data analysis of accredited GPs interested in GP – Hospital patient data exchange either through Fax or
E – Mail or through online login to the hospital’s intranet portal.
- Designing of MS – Word format templates for facsimile transmission and online forms using HTML & CGI (Front End) and RDMS (Back End) of Comprehensive Patient Discharge Summary, Notification of Discharge, Notification of Admission and Emergency Care report to GP, which is a part of Discharge Referral System Project of Sydney Adventist Hospital
Workshops attended during Employment :
Attended Training Workshop through HPS with Terry WALSH of GSI

Consulting in 2008 at Adelaide on :
- Systematizing the Business for a life without distress
- Managing the Business with Process to satisfy customers and the organization
- Leading and developing your team for superior performance