Job Description:
Pioneer in the discovery and commercialization of oncology therapies has an immediate need to fill a key role for their organization in Newark, Delaware. The Associate Director of Safety Systems will be responsible for the management and maintenance of the pharmacovigilance database, including workflows, configurations, products and licenses, and reporting. Responsibilities:
Additional Info:
Relocation to Delaware is available. For consideration please forward resume to TMaksym@Jouleinc.com[Click Here to Access the Original Job Post]
Pioneer in the discovery and commercialization of oncology therapies has an immediate need to fill a key role for their organization in Newark, Delaware. The Associate Director of Safety Systems will be responsible for the management and maintenance of the pharmacovigilance database, including workflows, configurations, products and licenses, and reporting. Responsibilities:
- Configure and validate safety system upgrades, including: the development and execution of test scripts, to verify compliance to system configuration.
- Ensure all validation documentation meets auditable standards, including: validation plans, system design specifications, flow charts, test scripts, and user requirements
- Act as an “administrator” within safety system. These duties may include reviewing change requests, to ensure that these are appropriate prior to configuration, and determining the validation required.
- Identify and respond to issues concerning the safety system
- Assists, develops, and performs data retrievals for all pharmacogivilance needs; this may include: compliance analyses and metrics; review of safety profiles of company products; supporting internal auditors and inspectors from regulatory authorities
- Lead the full lifecycle of safety data retrieval activities: authoring, data query, validation, and publishing reports.
- Coordinate daily support of the pharmacovigilance safety system to ensure continuity of electronic and paper-based reporting.
- Support submission activities associated with expedited individual case safety reports (ICSRs) to both domestic and international regulatory agencies and distribution of ICSRs to appropriate parties
- Maintain pharmacovigilance electronic data storage, including: websites, shared folders, and document management system, websites; archive and retrieve pharmacovigilance safety material. Direct the management of all systems in pharmacovigilance, including: Empirica (signal detection system), MedDRA, ARGUS, and reporting systems,
- Oversee the installation, management and maintenance of ARGUSj, collaborating with counterparts in Japan
- Maintain and adhere to periodic report schedule; create aggregate submissions in a submission ready standard (i.e. PBRERs / PSURs / PADERs / DSURs).
- Produce / maintain and provide training on pharmacovigilance specific procedural documents that refer to the use of the Safety System
- Participate in establishing Data Entry Guidelines to ensure consistent and accurate data entry.
- Represents pharmacovigilance safety systems on cross functional teams, both internally and externally
- MUST have Global experience
- MUST have current experience with ARGUS and with ARGUSJ (Japanese)
- MUST have management experience, leading and developing teams
- B.S. Degree in Bioinformatics, Computer Science, or other technical discipline
- M.S. Degree is preferred but not required
- At least six years of experience in Systems Management or in Safety Data Management
- Experience installing ARGUS J (Japanese)
- Must have experience in the pharmaceutical or biotechnology industry
Requeriments :
Skills :
Areas :
Additional Info:
Relocation to Delaware is available. For consideration please forward resume to TMaksym@Jouleinc.com[Click Here to Access the Original Job Post]