Current Opening in Parexel for Drug Safety Associate

There are opening for Drug Safety Associate in Parexel International. The details are as follows :

Title              : Drug Safety Associate 

Location       : Hyderabad, Andhra Pradesh, India 

Department  : Pharmacovigilance 

Company Profile of Parexel 

PAREXEL International is a contract research organization (CRO), based in Waltham, Massachusetts. It provides services for companies in the pharmaceutical, biotechnology and medical device industries, including consulting, clinical studies and market launch. PAREXEL employs more than 11,300 people worldwide in over 50 countries and has supported all of the top 20 leading biotechnology companies, all of the top 10 largest pharmaceutical companies and nearly all of the 50 best-selling drugs on the market. The company provides services during all phases of the development of a drug, from planning to commercialization. It includes strategy development, clinical trials management, data management, biostatistical analysis, regulatory affairs, drug development consulting, medical marketing, training, publishing and advanced eClinical technology solutions.

Qualification

• 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

Skills & Experience

• Clear 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 computer applications including database management
• Related experience gained in Pharmacovigilance or a healthcare environment

 Job Profile

• 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:
• collection and review of endpoint packages
• review and follow-up laboratory alerts
• review and follow-up patient eligibility for inclusion / exclusion in clinical trials
• review and follow-up protocol violations
• 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

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