Hendre Moolman at CK Clinical is currently recruiting for a Pharmacovigilance Specialist to join a successful pharmaceutical company based in Cambridgeshire.
Pharmacovigilance Specialist Job Description
As Pharmacovigilance Specialist, you will be responsible for the overall coordination of serious adverse event (SAE) processes and database activities and the PVG coordination of sponsor and investigator meetings. You must maintain knowledge and understanding of SOPs and WPDs; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues. In addition, you will help prepare for and attend audits, kick-off and investigator meetings. The Senior Safety Specialist will act as mentor to new staff.
Further responsibilities of this Pharmacovigilance Specialist position include:
- Set up and maintain accurate data within the SAE tracker for all assigned projects.
- Set up and QC of data entry into safety database.
- Prepare and submit client SAE notifications.
- Review SAE reports for completeness, clinical consistency and agreement with source documents.
- Identify and send SAE queries to investigator sites either directly or through CRAs.
- Prepare Physician Assessment Form and ensure that medical monitor assessments of SAE documents are completed and distributed according to project requirements.
- Coordinate SAE activities for assigned projects, including study start-up, maintenance and close-out activities, SAE reconciliation, budget tracking and forecasting for assigned studies.
- Produce and maintain accurate status and metric reports for assigned projects.
- Prepare and QC patient SAE narratives.
- Produce accurate SAE data for reporting purposes (including regulatory reporting).
- Prepare and submit expedited safety reports and manage the reporting process.
- Identify project resourcing needs.
- Promptly advise the Manager/Associate Director/Director, Pharmacovigilance of any significant safety and regulatory concerns.
- Develop and maintain a cooperative working relationship with project team members.
- Attend and professionally represent PVG at 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.
- SAE reconciliation – 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 internal training initiatives 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.
- Prepare and give presentations to client and/or project teams.
- Coordinate sponsor, investigator and Data Monitoring Committee (DMC) meetings.
- Perform internal audit activities for departmental processes and procedures.
- Assist with external audit activities.
- Provide input to SOP/WPD generation and revisions.
- Exercise independent judgement to manage and resolve safety issues for standard non-complex projects, including PVG coordination of sponsor and investigator meetings, with minimal supervision.
- Develop supervisory and mentoring skills for standard SAE processing, study set-up, maintenance, close-out and narrative generation.
- Oversee and give direction to a project group/team.
As Pharmacovigilance Specialist, you will have the following qualifications and experience:
- Bachelor’s degree in Life Sciences or Nursing
- Proven medical/clinical experience or clinical/safety experience and SAE processing experience/or clinical safety experience
- In some cases other appropriate education and professional training, for example vocational Health Care Professional qualifications
How to apply:
For more information or to apply for this Pharmacovigilance Specialist position, please contact Hendre Moolman on 01438 870 023 or email email@example.com. Please quote reference CL22783 in all correspondence.