Title: Drug Safety Specialist
Department: Pharmacovigilance
Location: India - Andhra Pradesh - Hyderabad
Employment Type: Full Time
Job Type: Regular
Company Profile:
PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
Description:
JOB DESCRIPTION
Job Title Drug Safety Specialist
Department Worldwide Medical Services
SBU Clinical Research Services (CRS)
Location Hyderabad
Essential Function
The Drug Safety Specialist will provide technical and process-related expertise 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/Team Manager PV Operations
Directly Supervises None
Provides Work Direction to Drug Safety Assistants, Drug Safety Associates
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, Regulatory Authorities, Central Ethics Committees
Key Accountabilities
¿ Develop project specific safety reporting procedures and workflows and provide guidance to the team on the procedures
¿ Develop project specific safety database customization and data entry guidelines
¿ 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
¿ Case reconciliation ¿ coordinating activities with Data Management personnel
¿ Line listing and tabulation generation for safety reports i.e. periodic safety reports, ad hoc safety reports etc
¿ Quality control of case reports, line listings and tabulations
¿ Maintaining local drug safety reporting requirements
¿ Regulatory authority reporting (electronic and hard copy)
¿ Literature reviews
¿ Ad hoc requests / queries
¿ Provide drug safety and project specific training
¿ Quality Assurance activities such as preparing for audits, development of templates, checklists and guidelines
¿ Create and maintain project specific working files, case report files and project central files
¿ 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 drafting, writing and editing of protocols and CRFs
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 preparing relevant procedures covering the above medical monitoring activities
o review study specific Model ICFs according ICH/GCP criteria
¿ Act as the Medical Monitoring Representative in project teams, as appropriate
¿ Participate in client meetings / investigator meetings/ project specific training sessions
¿ Delegate work as appropriate to Drug Safety Associates and Drug Safety Assistants
Skills
¿ Sound knowledge of drug safety and the drug development process
¿ Knowledge of and ability to interpret and apply global safety regulations.
¿ Experience in data analysis and evaluation of safety data
¿ Demonstrated competence in processing, evaluating and reporting safety information in compliance with the regulations
¿ Good presentation skills
¿ Excellent interpersonal skills
¿ Excellent verbal / written communication skills
¿ Good time management skills
¿ Team player
¿ Client focused approach to work
¿ Experience with computer applications including database management and pharmacovigilance related computing systems
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:
¿ Drug safety knowledge and two years of experience experience in Safety Database
¿ Experience in working in drug development and/or healthcare environment
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