Safety Scientist - 22-148
Fully Remote
Description

The Safety Scientist in the Drug Safety and Pharmacovigilance Department at Elevar Therapeutics is a key role in a highly visible position within the organization in the Safety Sciences Division. This individual is responsible for two key activities assuring patient safety: signal detection, and the efficient and timely and efficient processing of aggregate reports such as but not limited to DSURs. The signal detection process includes the assembly of the appropriate information, whether from clinical data, epidemiologic data, or toxicology data; drafting of the appropriate documents discussing the data and describing the analysis of the information regarding a potential signal; and then the communication of those documents to the appropriate Safety Management Team (as put forth in the CIOMS Working Group VI Report) and possible escalation within the organization. This paradigm will be followed whether products are in development or in the marketplace. The Safety Scientist will work in conjunction with the DSPV physician (also in the Safety Sciences Division) supporting assigned products. Also, this individual will draft or contribute to the appropriate documentation of the procedures followed in conducting safety surveillance and aggregate reporting either as SOPs or work instructions. Depending on experience, the Safety Scientist may serve as Head, Safety Sciences or may report into the Head of the division. A good knowledge of GCP and appropriate FDA/ICH guidance is expected. This is a remote-based position.


Responsibilities:

  • The Safety Scientist, working with the Safety Officer(s) for assigned products, will drive signal detection and the compilation/analysis of aggregate reports in both clinical safety and post-marketing approval pharmacovigilance settings
  • Contributing author to aggregate reports (DSUR, PBRER, PSUR) and IB; may be called upon to lead in the drafting of an aggregate report
  • Member of Safety Review Team assessing safety data for safety signals and risk management
  • Reports to the Head, Safety Sciences; the candidate may also be considered for Head, Safety Sciences, depending on managerial experience
  • Performs routine and ad hoc safety surveillance activities, such as signal detection, literature review and risk management for one or more programs
  • Serves as Secretary of Safety Management Teams for assigned products
  • Participates in and prepares responses to health authorities
  • Reviews and provides input on protocols, statistical analysis plans, CSRs and other clinical study-related documents
Requirements
  • Health care provider (MD, DO, PharmD, DDS, etc.) status preferred, experience acceptable 
  • Minimum of 5 years working in the role of pharmacovigilance scientist
  • Experience working in small start-up environment required; experience working in large pharma preferred
  • Strong knowledge of clinical development process
  • Ability to prioritize multiple tasks and make deliverables
  • Strong knowledge of drug approval process in the US and EU; knowledge of process in Latin America, Asia and Japan preferred
  • Experience with working with contract service providers for case processing, aggregate reporting
  • Experience with regulatory inspection readiness and company audits; excellent oral and written communication skills