Drug Safety Associate

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Careers APPLY HERE Apply Button will redirect you to recruiters resume management system PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in approximately 70 locations throughout over 50 countries around the world, and has more than 13,000 employees. At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You'll be surrounded by supportive leadership and a brilliant team who share a common goal - to improve the lives of millions of patients. Designation Drug Safety Associate Job Description THE CLEAREST PATH TO CAREER FULFILLMENT STARTS WITH PAREXEL. At PAREXEL, we believe that the power to work independently and intelligently should be yours every day. Your ability to understand our clients' needs and achieve quality results is critical to our reputation as one of the best clinical research organizations (CROs) in the world. On your PAREXEL journey, we support you with leading-edge technology, the highest caliber team members, and managers who know your strengths. If you're looking for flexibility and work-life balance, we're here to listen and help you move forward with your individual career path. Bring your talent to PAREXEL and surround yourself with colleagues who share the same dedication and passion-to deliver life-saving treatments to patients worldwide. Job Title Drug Safety Associate Department Worldwide Medical Services SBU Clinical Research Services (CRS) Location Hyderabad 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 Related experience gained in Pharmacovigilance or a healthcare environment 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 Desired Profile   Experience 1 - 3 Years Industry Type Pharma / Biotech / Clinical Research Role Clinical Research Associate/Scientist Functional Area Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology Education UG - Any Graduate - Any Specialization PG - Any Postgraduate - Any Specialization Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required Compensation:  Not disclosed Location Hyderabad / Secunderabad Keywords Drug safety associate Contact Anirudh Muppirala PAREXEL International (India) Pvt Ltd  Job Posted 2015-02-18 18:26:33.0 Reference pare-10040550