Parexel is looking for a Drug Safety Specialist with drug safety case processing experience to join our team in North America!

The Drug Safety Specialist will provide technical and process-related support to drug safety management (clinical trial and post-marketed), ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

Key Accountabilities:
Global Pharmacovigilance Processing Group (GPPG):

• Monitoring of incoming reports from various sources viz mailboxes, literature searches, etc.
• Triage of incoming reports for completeness, legibility, and validity, including literature abstracts/articles/citations
• Perform a check on overall medical cohesiveness and consistency of the document
• Compares and analyzes data provided by the affiliate with the data available on client application
• Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool
• Creates the case in the safety database and performs Data Entry into safety database
• Performs clear and accurate data capture of cases in accordance with the client conventions/guidelines and Standard Operating Procedures (SOPs)
• Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events
• Ensures MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”
• Request follow-up and perform query management, as applicable
• Prepares medically cohesive case narratives based upon the reported information
• Routes the case to the next workflow state as applicable in the safety database
• Performs quality checks/validation checks
• Performs literature searches as per search strategy, performs data entry of valid cases into the safety database
• 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.)
• Generation, reporting and reconciliation of compliance metrics in collaboration with internal and external partners and stakeholders, where applicable

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
• Good presentation skills
• Analytical and problem-solving skills
• Clear understanding of the regulatory submission process
• Proficient in database/literature searches
• Excellent interpersonal skills
• Excellent verbal / written communication skills
• Excellent organizational and prioritization skills
• Ability to work collaboratively and effectively in a team environment
• Client focused approach to work
• Ability to evaluate data and draw conclusions independently
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Computer proficiency, IT skills, the expertise and ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/PowerPoint)

Knowledge and Experience:

• Related experience in drug safety/ pharmacovigilance case management is preferred
• Argus case processing and workflow management experience preferred.
• Good knowledge of medical terminology
• At least 3 years of Safety case processing experience is preferred.

Education:

• Degree in Sciences, Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.) or equivalent experience.
• A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.