PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post:
- Drug Safety Associate
Position: Drug Safety Associate
Job Description:
Essential Function
The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
Relationships
Reports To Regional Head of PV Operations/ Associate Team Manager PV Operations Directly Supervises None
Provides Work Direction to Drug Safety Assistants
Works Closely with All Medical and PV staff, Project Management and members of the Clinical Operations Group
External Relationships Clients, Healthcare Professionals, Consumers, Consumer Representatives
Key Accountabilities
* Triage of incoming reports for completeness, legibility and validity
* Initial data entry of case reports into safety database / tracking system
* Assessment of case reports for seriousness, causality and expectedness
* Requesting follow-up i.e. written, telephone
* Adverse event (AE) and drug coding
* Writing case narratives
* Create and maintain project specific working files, case report files and project central files
* Assist with additional Drug Safety Specialist activities as required
* Inform Medical Project Managers and Regional Head of PV Operations of potential change-in-scope of projects
* Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities such as:
o collection and review of endpoint packages
o review and follow-up laboratory alerts
o review and follow-up patient eligibility for inclusion / exclusion in clinical trials
o review and follow-up protocol violations
o review study specific Model ICFs according ICH/GCP criteria
* Participate in client meetings / investigator meetings / project specific training sessions
* Delegate work as appropriate to Drug Safety Assistants
Candidate Profile:
Skills
* Understanding of drug safety and the drug development process
* Analytical and problem solving skills
* Excellent interpersonal skills
* Excellent verbal / written communication skills
* Time management skills
* Team player
* Client focused approach to work
* Experience with basic computer applications
Education (one of:)
* Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification
* Associates/diploma degree in any of the above with appropriate work experience
Language Skills
* Fluent English
Experience:
Related experience gained in Pharmacovigilance or a healthcare environment
Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10022352
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Position: Senior Clinical Database Programmer
Job Description:
Essential Function
The Senior Clinical Database Programmer provides technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies. In addition, the Senior Clinical Database Programmer can fill the Database Primary role on projects, and liaise with sponsors, Data Operations Leader, and other functional areas as required. There are two specific functions that may be filled by the Senior Clinical Database Programmer, dependent on skill sets and experience; Clinical Systems and Support Programmer and Database Programmer. Relationships Reports To Manager, or above Directly Supervises N/A Provides Work Direction to Clinical Database Programmer I & II, Technical Analysts, Other members of the GRO department as appropriate Works Closely with Technical Analysts and Statistical Programmers, Data Processing, Biostatistics, Data Operations Leaders, QMG, RRC, Medical Writing, IT, Proposals and Business Development External Relationships Sponsors, Third Party Vendors, Auditors
Candidate Profile:
Key Accountabilities
* Deliver best value and high quality service.
* Ability to fill Database Primary role on projects. The Database Primary will:
o Provide input into and negotiate clinical programming timelines. Ensure that timelines are adhered to.
o Coordinate and lead a programming team to successful completion of a study within given timelines and budget.
o Actively assume activities on a project, as required.
o Monitor project resourcing and identify changes in scope.
Education
* First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience.
Language Skills
* Excellent English written and oral communication skills.
Minimum Work Experience
* Relevant Clinical Trial industry experience
* Experience working with at least one system used within the Clinical Trial process (e.g., SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS, Medical Safety Reporting)
Experience:
6 years of experience in Statistical Programming, Tables, listings and Figures.
Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10022109
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Position: Customer Care Representative
Job Description:
Essential Skills
- Provide users/clients prompt, friendly, courteous and helpful service for all supported projects.
- Properly document and update issues entered into the issue tracking tool and ensure the issues are worked to resolution or closure per the project SLA and/or CCC processes.
- Resolve product/project related issues with assistance of CCC Manager, Senior Support Specialist, and Support Product Lead and/or Support Team Lead.
- Conduct system monitoring for supported Perceptive products/projects.
- Perform administrative tasks including, but not limited to data entry, sending out correspondence, and filing.
- Travel to alternate work location in the event of a disaster.
- Assist with shift coverage for all shifts.
- Ability to work a rotating shift to cover weekends as scheduled by the CCC Manager.
College Degree with 2 years experience in voice based call center. from an Inbound call center a plus.
Experience: 3 - 4 yrs. of experience in inbound International Call Center (Voice based).
Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10022628
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Position: Medical Research Reviewer
Job Description: Provide expert medical interpretations on imaging-related projects where imaging is used to evaluate the safety or efficacy of an investigational drug or device.
Candidate Profile:
M.D. or DNB (or country specific equivalent) in radiology, One year clinical practice or research is preferred but not required.
Experience with imaging clinical research is desirable.
Prior experience in a business environment desirable.
Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10022374
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