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Drug Safety Specialist (Safety Case Processing)

Parexel International Corporation

USA - Any Region - Home Based

Parexel is looking for a Drug Safety Specialist with 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, Eudravigilance, 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provided by the affiliate with the data available on client application Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool Creates the case in the safety database and performs Data Entry into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 QualificationsSkills: 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 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.

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination. EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job posted: 2022-05-27

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