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ID-Clinical Candidates Job - Senior PVG Scientist


Reference IDSS800103DP
Title Senior PVG Scientist
Description The Senior PVG Scientist is responsible for the overall co-ordination of the serious adverse event (SAE) processes, the co-ordination of database activities, and oversees budgets for assigned projects. He/she must maintain knowledge and understanding of SOPs and WPDs; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues; and effectively interface with project teams, client company, and investigators regarding SAE activities. The Senior PVG Scientist is involved in the preparation and revision of department SOPs and WPDs. He/she also prepares for, and attends, audits. The Senior PVG Scientist has supervisory responsibilities.


This position relates to the day-to-day handling of SAEs in a timely manner in accordance with current global regulations and ICH/local guidelines. Safety is a key performance measure for clients and is highly regulated. Associated with this position there is a high degree of liability. Errors made in collection of SAE data, SAE review, and SAE reporting could affect patient safety, the loss of current and/or future contracts as well as regulatory/legal action.

Responsibilities

  • Set up and maintain a tracker for all assigned projects.
  • Prepare and submit client SAE notifications.
  • Review SAE reports for completeness.
  • Identify and send SAE queries to investigator sites either directly or through Clinical Research Associates.
  • Prepare Physician Assessment Form.
  • Prepare patient SAE narratives.
  • Enter data into safety database.
  • Produce accurate SAE data for reporting purposes (including regulatory reporting).
  • Prepare and submit expedited regulatory reports.
  • Co-ordinate SAE activities for assigned projects.
  • Keep up-to-date with the status and metrics of assigned projects.
  • Promptly advise the PVG Team Manager of any significant safety and regulatory concerns.
  • Develop and maintain a co-operative working relationship with project team members.
  • Attend ERMs, PRMs, team meetings, client meetings, and other appropriate meetings, as required, for assigned projects.
  • QC safety-related paper documents/electronic data/database entries prepared by others.
  • Review Data Management listings, database reports, and validation checks
  • Adhere to corporate policies, SOPs, WPDs, other guidance documents, sponsor SOPs/directives and project specific WPDs.
  • Adhere to current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents, and safety issues.
  • Participate in Ground Rounds to keep up-to-date in Safety regulations, processes, and company policy regarding Safety issues etc.
  • Review regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
  • Provide and give presentations to client and/or project teams.
  • Provide input to SOP/WPD generation and revisions.
  • Troubleshoot.
  • Develop supervisory and mentoring skills.

Education and Experience:

  • Life Science degree
  • Undertaking Dip or MSc in PVG or similar discipline
  • Minimum 3 years experience in PVG Scientist (or similar position) and/or in a pharmaceutical, clinical or health care setting.

Knowledge, Skills and Abilities:

  • Demonstrated proficiency working to SOPs, WPDs and ICH-GCP
  • Experienced in study start-up, database set-up, and project close-out
  • Experience of a number of different trials in different therapeutic areas
  • Proficient at administrative tasks and project administration
  • Multiple language capabilities
Salary Excellent package offered
Location Europe
Contact david.proudfoot@id-ss.com

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