Job Description
Drug Safety Specialist
locations
United States – Northeast – Remote
job requisition id
R0000008704
When our values align, there’s no limit to what we can achieve.
At Parexel, we all share the same goal – to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special – a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.
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- Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool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.