Quality, PV and Compliance Specialist
- Employer
- Thornshaw Recruitment
- Location
- Dublin (City), Leinster (IE)
- Salary
- Neg
- Start date
- 4 May 2022
- Closing date
- 1 Jun 2022
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- Discipline
- Clinical Research, Pharmacovigilance, Quality
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
On behalf of my client, a global pharmaceutical company based in Dublin, we have a new vacancy for a PV, Quality & Compliance Specialist.
The PV Quality and Compliance Specialist (QCS) main role involve supporting the Snr. Pharmacovigilance Quality and Compliance Manager (PV QCM) in oversight of the PV QMS by performing the relevant delegated activities. PV Implement and administer Pharmacovigilance quality management systems to ensure best practice and continuous improvement of the Pharmacovigilance department.
Key Responsibilities:
- Support the Snr. Pharmacovigilance Quality and Compliance Manager (PV QCM) in ensuring that detailed systems and procedures are in place in accordance with Group Policies and Group Operations Quality and Compliance (GOQC) PV Policies and relevant guidelines of external regulatory and professional organizations. Review of Group PV written procedures to ensure they are compliant with GOQC PV policies and adhere to EU legislation and guidelines for PV. Assist PV QCM in planning and coordination of the GOQC, APTL MAH audits and Regulatory Authority Inspections. Assist PV QCM in coordinating the self-inspection schedule as per relevant procedures. Provide guidance and advice on implementation of GOQC PV policies for all appropriate Affiliates and Departments on a continuous basis. Monitor Key Performance Indicators (KPIs) for all relevant internal and external departments/organisations as required by the business based on data reported from PV Quality and Compliance Associates (PV QCA) and other relevant teams (e.g., PV Scientists, PV Medical Writers, PV Service Providers). Compile monthly and ad-hoc compliance reports highlighting any non-compliances to KPIs / procedures, referring to the relevant deviation or investigation. Identify trends with respect to non-compliance with KPIs; document and investigate with input from relevant team and PV QCM. Coordinate the monitoring of Group PV, PV Partner and Service Provider compliance with written agreements (e.g., Safety Data Exchange Agreements, PV Agreements) as per the relevant procedures.
Qualifications & Experience:
- Life Sciences or Pharmacy degree. 2 plus years’ experience in Pharmacovigilance / Quality Management Systems Deviation and CAPA experience (writing/review) Audit and Self-Inspection (Participation/CAPA Report Response) Written procedures (SOP/WIs Writing or Peer Review) Information gathering, monitoring and report writing. Attention to detail.
Problem solving.
For full job spec and details contact Tina at +353 1 2784701 or email your CV to tdunne@thornshaw.com
Thornshaw Scientific is a division of the CPL Group www.thornshaw.com
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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