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Post Market Surveillance Specialist

Req #: 170006LA_en
Location: Newbury, ENG UK
Job Category: Quality
Date Posted: 8/11/2017 10:46:51 AM
Baxter International

Description

Job title:
Post Market Surveillance Specialist
Reporting to:
Head of CQA, UK and Ireland
Issue date:
July 2017
Supersedes:
January 2014
Business:
Multi-business Support
Sub business:
Quality
Group:
CQA EMEA
Country:
UK
Location:
Compton
Job Code:
ZQ2900
BPG:
D
 
 

SUMMARY

 
 
Act as UK CQA point of contact in the absence of CQA Manager.
 
Co-ordinating and providing responses to the MoH (MHRA) to complaints sent by external customers directly to the MHRA and any follow up questions to Med Dev Vigilance Reports filed.  In addition, provide updates to Field Corrective Actions, as routinely requested, plus any other general question directed to CQA by the MHRA. This is in addition to general Post Market Surveillance.   

Post Market Surveillance is a core activity in that it provides a service to our key stakeholders (customers, business, competent authority and third party). In addition it has a direct impact on Baxter’s ability to comply with mandatory legislation.
 

ESSENTIAL DUTIES AND RESPONSIBILITIES

 
Job Description
 
1. Post Market Surveillance (PMS) Activities:
 
a) To be the main point of contact for all PMS activities.
 
b) To make sure the PMS KPI is achieved on a monthly basis. Responsible to provide a rationale to senior management incase the KPI is not achieved.
 
c) Arrange/attend customer visits as required
 
d) Receive product complaints from UK.
 
e) Log product complaints into the Global Complaint Management Tracking System.
 
Determine the complaint type and accurate transcription of product type and related codes. Forward on to Central Complaint Management (CCM) which is under the remit of the EMEA Field Surveillance & Viglinace (EFS&V) organisation.
 
f) Identify and report adverse events to the Pharamcovigilance organisation.
 
g) Complaint sample management
 
h) Follow-up and provide final response to Healthcare Professionals and other customers (e.g. Distributors, third parties)                                                      
 
i) Respond to queries from the EMEA Field Surveillance & Viglinace (EFS&V) organisation and Medical Safety.
 
j) Co-ordinate and respond to MoH (MHRA) requests according to the National Regulations and answer any subsequent questions in collaboration with the Head of CQA, UK, EMEA Field Surveillance & Vigilance (EFS&V) organisation and other relevant functions such as the MP Operations (MoH Communications) in the US and the Quality Representatives at the Manufacturing Plants.
 
k) Answer questions from the Heath Care Professionals and other customers.
 
l)   Provide CQA input to contracts with external partners (Licensing, Distributors etc). from Sales and Marketing and retain current sub-master for reference purposes.  Ensure adherence to the contracts with regard to post-market surveillance and field safety corrective actions.
 
m)  Prepare PMS Reports as required for business, quality reviews etc.
 
                                                                           
2. Support Implementation and execution of Field Corrective Actions (FCA):
 
  1. Support implementation and execution of all FCAs according to European and local procedures.
     
  2. Ensure process and procedures for FCA-handling are in place.  Review FCA related documentation and update according to new regulations/guidance.
     
  3. Coordinate requests from the authorities with EMEA Field Surveillance & Vigilance (EFS&V) or other functions and provide timely answers.
     
  4. Cooperate and/or inform other local and European departments as necessary.
     
    3. Local Regulation Activities:
     
    a)  To monitor local Product Surveillance related regulations and inform relevant Product Surveillance organisation members on all changes.
     
    b) To regularly screen the Health Authorities website (medical device alerts, field corrective actions, newsletters, regulations,).
     
    c)   Establish relationships with the appropriate organisations within National Competent Authorities.
     
    4. Training:
     
    a) Train and record on relevant procedures as per Isotrain curricula or other means (e.g. We Comply)
     
    b) Perform training to the business on PMS/FSCA, e.g. the Sales Force and customer facing Employees, Technicians as required
     
     c) Perform training to new starters and provide continuous support
     
     
    5. Product Surveillance (MDR) Backup
     
  5. To log MDR’s into the tracking system (PMDA).
     
  6. To answer the queries of the Central Team Product Surveillance and Medical Safety.
     
  7. To support the submission of Medical Device Vigillance Reports to the local Health Authorities according to the national regulations and answer any subsequent questions in collaboration with the CTPS, Medical Safety and relevant functions.
     
    6. Issue OEM Certificate of Compliance
     
  8. Liaise with the supply chain analyst, collaborate all individual component certificates and prepare a final release Certificate of Compliance.
     
  9. Archiving the certificate in Quickcert.
     
  10. Releasing the inventory on ERP system ( WISE/JDE or equivalent).
     
    7. Supplier Corrective Action Requests (SCAR)
     
  11. Raise SCAR’s when required.
     
  12. Coordinating SCAR’s with SQM.
     
  13. Documenting the details and final correction report in Trackwise.
 
8. CAPA Related Activities:
 
  1. Open CAPA’s appropriately for the PMS function.
     
  2. Request CAPA’s from other functions if needed.
     
  3. Attend the monthly CAPA Review Board (CRB) and provide CQA input.
     
  4. Host CRB in the absence of CQA Manager.
     
 
 
9. Others:
 
a)    Become a competent expert user for the QA aspects of the ERP system (WISE/JDE or equivalent), including Partmaster maintenance, product release and product holds.
 
b)    Support internal quality audits.
 
c)    Support or lead Local, European or Corporate Projects.
 
d)    Conduct other related quality duties, as defined by Head of CQA, UK and Ireland.

Qualifications

Education

 
The function requires a degree in the scientific field
 
 

Functional/specific competencies

 
  • Excellent interpersonal and communication skills
  • Ability to liaise with the different functions involved
 

Skills

 
 
Language skills
 
Languages
Spoken
Written
Read
  • English
 
 
Computer skills
 
Description
  Basic
Word, Excel, Lotus notes
  Particular knowledge required
 
Trackwise 7 and 8 Quality System
 
Technical skills
 
  • Tracking and understanding of applicable country regulations
  • ISO 9000 and ISO 13485 knowledge.
  • Corporate quality requirement knowledge.
  • Presentation and trainer skills.

Experience

 
Number of years of experience:
3 years
Field of expertise:
Preferably Quality or Regulated expertise
Experience in dealing with the MHRA
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