www.ppdi.com Pharmaceutical Product Development Delhi : Safety Specialist

[muthukalee]

ppdi.com
Safety Specialist

Description :

Duties and Responsibilities :
Coordinate serious adverse event (SAE) processes and database activities
Develop an understanding of budgets and forecasts for assigned projects
Familiar with and understand PPD SOPs and WPDs; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues.
Effectively interface with project teams, the client company and investigators regarding SAE activities.
Prepare for and attend audits, kick-off and investigator meetings. Demonstrate the ability to prioritize and organize workload

Qualifications :
Bachelor's degree in Life Sciences or Nursing
Minimum 2-3 years medical/clinical experience or clinical/safety experience and minimum 1 year SAE processing experience/or clinical safety experience
In some cases other appropriate education and professional training, for example vocational Health Care Professional qualifications, certified/licensed health care profession and/or relevant research experience may be substituted provided the individual possesses the required knowledge, skills and abilities

Skills and Knowledge :
Competent in the use of Microsoft Word, Excel and PowerPoint ? Safety database skills
Good knowledge of applicable SOPs, ICH GCP and awareness of pharmacovigilance regulations
Ability to review SAE data for completeness and prepare patient narratives from appropriate documentation
Competent at administrative tasks and project administration activities
General understanding of pathophysiology and the disease process, more detailed knowledge of relevant therapy areas as required to process SAEs
Good oral and written communication skills and ability to work within a team or independently as required

Job : Pharmacovigilance

Primary Location : Asia Pacific-India-Haryana-New Delhi

Apply : https://ppdi.taleo.net/careersection...Xg3Luxaw%3D%3D

About us :
PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 44 countries and more than 11,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.

Contact us :
PPD Pharmaceutical Product Development
4th Floor Statesman House
Office no. 13.01 to 13.03
Barakhamba Road
Connaught Place
New Delhi 110001
India
http://www.ppdi.com/

[Guest-IJT]

Name : TAQUI IMAM
Email : staquimallick AT gmail.com
Designation / Skillset : SAFETY OFFICER
I AM INTRESTED IN ONLY SAFETY JOBS.

Resume :
Carrier Objective
I am looking for a carrier which offers avenues for carrier growth and self development and attribute towards insuring speedy growth and expansion of the organization that offers me opportunities to work as well as to enhance my knowledge.
Educational Qualifications
o B.A (Hons) From Aligarh Muslim University UP (2008) (Correspondence)
o Intermediate (10+2) in Science with PCM+ELECTRONICS from BIEC Patna (2001)
o (s.s.c) Secondary School Certificate from Bihar Board Patna (1999)
Professional Qualifications
Six months Diploma in Fire and Safety from NILEM Chennai (2003) (Correspondence)
One year Diploma in Industrial Safety from IIMT Chennai (2002).
MBA in HR from NIBM Chennai (2010 ) (Correspondence).
Computer Skills
- Familiar with windows MS Office and Internet.
(Responsibilities Jobs- Experience-Above 8 Years)
1. Recently working with Dresser-Rand Naroda Ahamadabad Gujrat as a Sr. HSE Officer.
2. EHS Sr. OFFICER M/s Jonhnson Matthey Chemicals India , Panki Kanpur UP
Since- 8/1/2011 to 6/4/2011.
3. EHS Sr. Officer – Technimont ICB LTD IPCL Dahej Gujarat
Since- 24/02/2009 to 30/11/2010
4 . Safety Officer – ECC LTD HPCL Mahul Mumbai Maharashtra
Since- 26/ 06/ 2006 to 31/ 12/ 2008.
5. Safety Officer – UB ENGG LTD ESSAR Steel Plant Hazira Surat Gujarat
Since- 5/12/2002 to 03/05/2006.
Responsibility Nature of Duties :
- Worked as a mission to avoid violations unsafe acts at the job site.
- Strict authorence to work permit procedures.
- Constant at herence to safe operating procedures & practices to avoid any accidents and illness.
- Conducting the safety training for the employees.
- Conducting weekly toolbox talk meeting on safety topics.
- To follow the PPE for workmen and visitors.
- Specific equipment for specific job like welding /cutting/grinding/jack hammering
- Sand blasting and radiography etc.
- Fall protection, excavation safety like barrication, benching, shoring, air testing
Gas testing and access ladders.
- Scaffolding erection procedures like guard rails, toe boards, cross bracings, sills
Base diagonal braces.
- For mobiles scaffolds caster fastening pins, locking casters access ladders etc.
- To arrange safety bulletin signage’s warning traffic, hazardous before job starting
- For heavy equipments like rollover protection, backup alarm, over all conditions
Licensed operators.
- For gas & electric welding operator protective proper acetylene on-off wrench
- Gauges & hoses conditions.
- For compressed gas & cylinders secured proper storage.
- Prepare safety plans for various jobs.
- Emergency procedure evacuation plan emergency alarm.
- Fire prevention fire fighting training, inspectors of fire hose cabinet’s water
Pressure.
- For heavy loads prepare lift plan.
- Hazards identification plans for specific jobs. To follow the work permits system at restricted areas. To check the G.F.C.I (Ground Fault Circuit Interrupter)
for electrical equipments.
- Use of various types of fire extinguishers.
- De-nailiing of wood, proper stacking of materials.
- To check the sealing, nylon belts wire ropes “D” shackles capacities.
- To ensure the company without any damaged to its properties no loss to its assets
- no loss of lives of work men without any major to minor injuries.
- Prepare of monthly reports like injuries reports. Monthly men hours major to
- minor accidents reports with in time to submit it to client.
- Safety training, Safety orientation, Safety meetings on weekly basis. Spill control
- dust control safety of environment. To gain good score in safety competition
- To enumerate company as outstanding performances.
- Management is dedicated to providing a safe and healthy work place and providing
- The equipments and procedures to safely over come any work place hazardous.
Storages and handling of chemicals :
- Hazardous data sheets shall be available for all chemicals.
- Only those persons should be allowed who have a reasonable knowledge of
the properties of the same, the possible hazardous and fast- aid treatment
Connected there with.
- All employees handling chemicals should be provided with suitable protective
Clothing, eye shields and safe handling equipments.
- The instructions issued by manufacturers in connection with transportation storage and handling of chemicals should be strictly followed and all storage containers be suitably labled.
- All employees must know the storing and handling of hazardous chemicals and important information about chemical reactivity.
Working nears crude Oil and Oil well fire safety rules :
- Crude Oil should always be treated as a hazardous, and flammable substances.
- Never drive trough standing crude oil. Several very serious fires have occurred
- when people have driven through crude oil and the engine or exhaust system ignited
the oil.
- Roads can become very slippery when covered with crude oil. The speed limit is
25 KPH when driving on roads that are coated with crude oil.
- Never work over standing crude oil. Supervision must have crude oil removed
before work can be done.
- All employees performing hot work near crude oil must be issued with a hot
work permit before starting works.
- All other safety requirements must be in place before a hot work permit can be issued.
- Several safety rules must be followed when working near oil well fires.
- Don’t start any work in the oil fields or refineries until your supervisor has a
Current permit.

DATE :-
TAQUI IMAM
PLACE :-
-------------------------------------------------------
More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4152148
Date & Time : 19th May 2011 2:57 PM (UTC)
IP Address : 65.124.85.125
Browser Info : Mozilla/5.0 (Windows NT 5.1) AppleWebKit/534.24 (KHTML, like Gecko) Chrome/11.0.696.65 Safari/534.24
Predicted Country ;: United States

[Guest]

F.BRENUBA JASMINE
brenuba.jasmine AT gmail.com

Aspire :
To achieve perfection and to reach higher position by updating myself and also by utilizing my
work experience and potential for the growth of an organization I am concerned with.
Professional career episode :
1. ICICI Bank call centre, Prince Infopark- Ambattur, Chennai.
Position :
Phone Banking Officer.
Department :

Investments and services.
Duration :

1st of November 2007 to 9th of April 2008 ( Through SAS Management and Services)
Responsibilities :

- Call the customers and introduce about the new products launched by ICICI-Prudential in ULIP.
- Fixing up appointments.
- Following the customers for closing the policy.
2. HDFC Bank,West Mambalam, Chennai.
Position :
Personal Banker.
Duration :
From July 18th 2008 to July 1st 2009 ( Through ADFC )
3. WIPRO BPO, New Delhi
Position :
Pharmacovigilance Officer (Since July2010)
Responsibilities :
(i) To receive inbound calls from the consumers and Health Care Professionals regarding the adverse events.
(ii) To generate the safety report based on the information gathered over the call.
(iii) To send the same for audit.
Position :
Pharmacovigilance Quality Analyst (Since Feb2011)
Responsibilities :
(i) To audit the Adverse Event Monitoring form made by the Pharmacovigilance Officers by listening the calls taken by them.
(ii) To close the necessary tools after audit.
Educational Qualification :
1999-2000 SECONDARY HCGHS School, Tuticorin 87.6%
2001-2002 HIGHER SECONDARY HCGHS School, Tuticorin 85.17%
2002-2006 B.PHARM SARP College, Vadakankulam 68%
(Dr. M.G.R University)
2011-2013 MSC. CRRA Sikkim Manipal University --- (Clinical Research and Regulatory Affairs)
Previous projects :
- Title : Anti- inflammatory activity of Kalanchoe pinnata and in combination

with Acalypha indica

Description : Compared the Anti-inflammatory activity of the above mentioned

plants, by taking their methanolic extracts separately and mixed up the
extracts. Then the result for the combination is compared with the

individual plant activity. The combination shows more
Anti-inflammatory activity than the individual plant activity.
- 60 days Hospital Training at Sacred Heart Hospital, Tuticorin
Duration :

October 2004 to November 2004.

Technical Skills :

Tools : MS-Office
Operating System : Windows 2000/XP
Extra Curricular Activities :

Listening music, Sports.

Personal Strengths :
- Self confident, highly efficient.
- Ability to learn fast working in a multi-tasking project-oriented environment.
- Enthusiastic & Optimistic.
- Leadership, Ability to plan and Organize.

[Guest]

PRAKASH REDDY.A
Email : prakashreddy.a AT gmail.com
OBJECTIVE : Seeking a challenging assignment in clinical data management and analysis professional with multi-faced competencies seeking team leading portfolios to shoulder broader responsibilities, thereby attaining career advancement.
EDUCATIONAL QUALIFICATION
- Master of Science in Biochemistry from University College, Kakatiya University, Warangal in 2004-2006 with 74.12%
- Graduate in Science (Biophysics, Genetics and Chemistry) from Nizam College, Osmania University, Hyderabad, Andhra Pradesh in 2000-2003 with 77.50%
PROFESSIONAL CHRONICLE
- Working as Senior Research Analyst in Thomson Reuters IP and Science, Hyderabad. from June 2007–Till date
Project # 1 :
Title : Derwent drug File
Designation : Research analyst.
Clients : Thomson Pharma, Derwent discovery.
Description :
Derwent drug file (DDF) is the only drug-focused, literature based biomedical database which was developed with the world's leading pharmaceutical companies to be the definitive source of drug literature and conference information. DDF covers all aspects of drug development, synthesis, evaluation, manufacture and use. The DDF coverage is truly international and journals are sourced from over 40 countries selected in collaboration with pharmaceutical industry representatives worldwide.
Roles and responsibilities :
- Acquisition of manuscripts or core content, analysis of manuscripts and electronic files, coding (mark-up of data) and resolving coding errors, manuscript editing, compiling and editing of content, proofreading and copy reading, quality control and verification.
- Preparing data for publishing products in print and/or electronic form.
- Organizing, medical coding and Indexing document-level classifications, Clinical trial research journals, to serve as a concise, informative summary of the contents.
- Responsible for writing and editing several types of documents such as abstracts posters and meetings/conferences.
- Research and write copy to the highest scientific and grammatical standards, with excellent technical accuracy and attention to detail.
- Quality assurance, onsite-offshore coordination with clients (internal and external).
- Sound knowledge in biological terminology, mechanism of action of drugs, organ systems and medicinal chemistry.
- Performing duties such as analyzing, keying, converting, coding, copy reading, editing, merging, rendering, loading or validation of data.
- Responsible for accuracy and completeness of work product.
- Creating and/or maintaining process or product specific documentation.
Project # 2 :
Title : Customized information services
Designation : Research analyst
Client : Pfizer
Roles and responsibilities :
- To provide confidential and customized service for prestigious pharmaceutical and biotechnology companies.
- To provide highly tailored literature service where articles are identified, indexed and abstracts according to client specifications and policy guidelines.
- Conducting analysis and coding via Pegasus production workflow system.
- Screening and coding/indexing Pfizer drugs from literature records (records include journal articles, editorials, review, meeting abstracts, conference proceedings and news reports.)
- Indexing : Coding the content of an article, focusing on the client product (Content includes clinical, animal, invitro, chemistry, microbiology and veterinary studies.)
- Also coding the content with critical information and relationships between subjects and the client products.
SKILL SET :
Operating System : Windows 98/2000/XP professional.
Packages : MS-office
Tools : PEGASYS, SAS
STRENGTHS
- Aspiring and ambitious professional, with planning, monitoring & resource-balancing skills & ability to handle multiple functions in high pressure environments, offering expertise in deciphering the true impact of any strategic decision with exceptional clarity while communicating the requirements & deliverables to the team members.
Achievements :
- University Gold medalist in Post graduation.
- Awarded “Best Employee” for 3 times in Thomson Reuters.