On behalf of our client, we are currently recruiting for a Safety Support Officer. This is an 8 month contract role initially, with potential for extension. The role is hybrid from the Dublin 9 office, with 3 days a week on site and 2 days a week remote.
Key responsibilities:
To provide business critical support to the Medical & Regulatory department primarily in the handling of safety information and customer complaints and by providing support to the safety function in Ireland and ad-hoc support to medical affairs.
Main job tasks:
Processing Safety Information including Customer Complaints
· Manage safety case processing in CCGlow and ensure on-time reporting to Customer Complaints (CC) and Global Patient Safety (GPS) in compliance with relevant regulations and internal copany requirements.
· Receive and process all complaint samples in line with local and global requirements
· Triage, interpret and report all spontaneous and solicited safety events including customer complaints received by the safety department to the third-party vendor for case data entry processing.
· Source data verification (SDV) of spontaneous and solicited safety information in CCGlow
· Conduct follow-up with patients and Healthcare Professionals, as applicable
· Utilise CCGlow to process safety information
Supporting the safety function
· Daily surveillance of the safety mailbox and affiliate contact log in CCGlow
· Daily review of GxP line listings for identification of reportable clinical trial SUSARs and serious medical device cases
· Liaise with internal company stakeholders e.g. GPS, company employees and external third-party vendors regarding safety and product complaint cases
· Submit expedited serious medical device cases, SUSAR reports (ICSRs) and Data Monitoring Committee (DMC) statements to relevant stakeholders as per legal requirements
· Review identified Irish medical journals for reportable safety information
· Perform QC of customer contacts according to company requirements
· Ensure reconciliation and QC process is followed for third-party vendors in line with company requirements and SDEA
· Ensure completion of C*TRACK for affiliate
· Ensure timely and clear communication to regulator authority requests
· Ensure compliance with relevant regulations, industry guidelines and company processes
· Archive customer complaint records in CCGlow
Ad-hoc support to the medical affairs department
Customer service
Act as back-up Customer Service Point of Contact (PoC) for Ireland to include liaising with the insourced customer service vendor to ensure vendor has the sufficient knowledge and capabilities to professionally manage customer contacts and ensure compliance with industry requirements.
QUALIFICATIONS
3rd level qualification, preferably graduate in Life Sciences
Eperience in pharmaceutical/ customer facing role
• Knowledge of pharmacovigilance systems & legislation
• Familiarity with medical terms
• IT skills
• Excellent written and verbal communication skills
• Effective project management, time management, organisation and prioritisation skills
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784703
#LI-LD1
