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Medical Information Officer
| Posting date: | 25 July 2024 |
|---|---|
| Salary: | £25,000 per year |
| Additional salary information: | • Membership to private healthcare scheme - Medicash • Membership to NOW Pension scheme • 20 days annual leave and 8 Statutory Bank Holidays (Pro rata for part time staff) • An additional day of annual leave for each completed year of employment capped at 25 days • Commitment to supporting ongoing CPD |
| Hours: | Full time |
| Closing date: | 09 August 2024 |
| Location: | MK3 6DP |
| Remote working: | On-site only |
| Company: | Red Line Pharmacovigilance Ltd |
| Job type: | Permanent |
| Job reference: | July 2024 MIO |
Summary
This role is a Technical Track for persons with a formal scientific qualification (at degree level) and who may not be registered as healthcare professionals. For this title, the Medical Information Officer may have some relevant experience of working in the Medical Information field, demonstrate good theoretical knowledge and or have relevant transferable skills. The Medical Information Officer must show an understanding of the Quality Management Process and over time competently apply a good level of knowledge and understanding of applicable company policies, procedures and working practice documents.
Front Line Enquiry Handling Duties
• Accessing electronic enquiries daily for incoming enquiries, from healthcare professionals or members of the public.
• Answering telephone calls received for medical enquiries and collecting all necessary details related to the enquiry.
• Logging medical enquiries, product quality complaints and Adverse Event reports onto a secure database.
• Electronic filing of supporting documentation into the METS system.
• Triage incoming enquiries to identify adverse events or product quality complaints, requesting a second opinion as needed.
• Provide high-quality front-line responses (non-technical) using the appropriate reference safety information.
Responding to Medical Information Enquiries
• Use the SPC/PIL or ASRs to provide a responses to patients and healthcare professionals seeking advice about products.
• Use the SPC/PIL to advise patients or healthcare professionals about the safe use of the product in various clinical situations.
• Deal with enquiries according to company operating procedures, using templates and other guidance documents.
• Meet customer (caller and/or client) deadlines and expectations, particularly in urgent or high priority clinical situations.
• Closing non-technical enquiries, adverse event reports and product quality complaints (PQCs) assigned to you.
• Conducting investigations to gather additional information for PQCs, such as batch numbers and expiry dates etc.
Handling of Product Quality Complaints
• Logging PQCs onto the Medical Information Enquiry Database.
• Conducting investigations to gather additional information for PQCs, such as batch numbers and expiry dates etc
• Liaise with the MAH Head Office to organise the return of the defective sample for further investigation.
• Allocate a PQC reference and reconciling these when exchanged or forwarded to client/partner companies.
• Follow and track PQC investigation and, where necessary, provide final outcome reports to the complainant.
• Communicating product complaints to the manufacturer or pharmaceutical company for investigation and monitoring their progress
Adverse Event Follow UP Investigations
• Forwarding adverse events to the relevant PV departments, as per procedure or contractual agreements.
• Conducting follow up investigations to gather additional information for non-technical adverse events.
• Closing non-technical adverse event reports that have been assigned to you.
Compliance Reporting
• Conduct ICSR reconciliation activities with PV Partners as per the safety data exchange agreements.
• Report all non-compliance issues to the Quality Assurance Manager and the QPPV for further investigation.
• Conduct monthly metric reporting to the MAH with PV oversight of activities conducted on their behalf.
• Notify the team of any changes to the product portfolio, stock issues etc, via the METS ‘Message Board’.
Continued Professional Development
• Participate in various team meetings and liaise with other colleagues about on-going projects.
• Manage the upkeep of your CPD Training Folder in preparation for audits and inspections.
• Participating in training, attending training courses to improve your skills
• Attending and actively participating in monthly Medical Information Team Meetings and monthly Red Line Team Meetings.
PERSON SPECIFICATION
MEDICAL INFORMATION OFFICER
Essential
Completed a formal scientific qualification at degree level.
Anu understanding of the importance of quality management.
Excellent telephone handling skills.
Customer focused
Excellent attention to detail
Polite, caring and embraces all forms of diversity with an ability to work well in a team.
Delivers on time to a high standard.
Proactive and responsible for the outcome of their work.
Works collaboratively to protect patient safety.
Has a professional and flexible approach with a ‘can do’ attitude, willing to ask for guidance and direction.
Committed to learning from others and develop an ability to work independently.
A-self-starter who can use their own initiative.
Excellent IT skills.
An ability to read complex company policy documents and adhere to procedures.
A good standard of written and spoken English with an ability to communicate effectively with a range of stakeholders to include colleagues, clients, patients, clinicians.
Able to prioritise their own workload and handle multiple medical enquires.
Engage in team meetings and the company’s Appraisal Review Scheme.
Desirable
Registered as a healthcare professional
At least one years’ experience gained in Medical Information
Gained experience in a Pharmacovigilance environment.
In return, we offer a range of company benefits and support ongoing CPD.
If you wish to be considered for less than full time hours, please state clearly your requirements in your application.
Please send your cv and cover letter and proof of right to live and work in the UK by attaching a scanned copy of the relevant page from your passport or any other official document to deepa.patel@redlinepv.co.uk by Friday 9 August 2024.
You must also provide proof of address as a supporting document to confirm that you live within the MK or one of the bordering counties as this is an office-based role.
Front Line Enquiry Handling Duties
• Accessing electronic enquiries daily for incoming enquiries, from healthcare professionals or members of the public.
• Answering telephone calls received for medical enquiries and collecting all necessary details related to the enquiry.
• Logging medical enquiries, product quality complaints and Adverse Event reports onto a secure database.
• Electronic filing of supporting documentation into the METS system.
• Triage incoming enquiries to identify adverse events or product quality complaints, requesting a second opinion as needed.
• Provide high-quality front-line responses (non-technical) using the appropriate reference safety information.
Responding to Medical Information Enquiries
• Use the SPC/PIL or ASRs to provide a responses to patients and healthcare professionals seeking advice about products.
• Use the SPC/PIL to advise patients or healthcare professionals about the safe use of the product in various clinical situations.
• Deal with enquiries according to company operating procedures, using templates and other guidance documents.
• Meet customer (caller and/or client) deadlines and expectations, particularly in urgent or high priority clinical situations.
• Closing non-technical enquiries, adverse event reports and product quality complaints (PQCs) assigned to you.
• Conducting investigations to gather additional information for PQCs, such as batch numbers and expiry dates etc.
Handling of Product Quality Complaints
• Logging PQCs onto the Medical Information Enquiry Database.
• Conducting investigations to gather additional information for PQCs, such as batch numbers and expiry dates etc
• Liaise with the MAH Head Office to organise the return of the defective sample for further investigation.
• Allocate a PQC reference and reconciling these when exchanged or forwarded to client/partner companies.
• Follow and track PQC investigation and, where necessary, provide final outcome reports to the complainant.
• Communicating product complaints to the manufacturer or pharmaceutical company for investigation and monitoring their progress
Adverse Event Follow UP Investigations
• Forwarding adverse events to the relevant PV departments, as per procedure or contractual agreements.
• Conducting follow up investigations to gather additional information for non-technical adverse events.
• Closing non-technical adverse event reports that have been assigned to you.
Compliance Reporting
• Conduct ICSR reconciliation activities with PV Partners as per the safety data exchange agreements.
• Report all non-compliance issues to the Quality Assurance Manager and the QPPV for further investigation.
• Conduct monthly metric reporting to the MAH with PV oversight of activities conducted on their behalf.
• Notify the team of any changes to the product portfolio, stock issues etc, via the METS ‘Message Board’.
Continued Professional Development
• Participate in various team meetings and liaise with other colleagues about on-going projects.
• Manage the upkeep of your CPD Training Folder in preparation for audits and inspections.
• Participating in training, attending training courses to improve your skills
• Attending and actively participating in monthly Medical Information Team Meetings and monthly Red Line Team Meetings.
PERSON SPECIFICATION
MEDICAL INFORMATION OFFICER
Essential
Completed a formal scientific qualification at degree level.
Anu understanding of the importance of quality management.
Excellent telephone handling skills.
Customer focused
Excellent attention to detail
Polite, caring and embraces all forms of diversity with an ability to work well in a team.
Delivers on time to a high standard.
Proactive and responsible for the outcome of their work.
Works collaboratively to protect patient safety.
Has a professional and flexible approach with a ‘can do’ attitude, willing to ask for guidance and direction.
Committed to learning from others and develop an ability to work independently.
A-self-starter who can use their own initiative.
Excellent IT skills.
An ability to read complex company policy documents and adhere to procedures.
A good standard of written and spoken English with an ability to communicate effectively with a range of stakeholders to include colleagues, clients, patients, clinicians.
Able to prioritise their own workload and handle multiple medical enquires.
Engage in team meetings and the company’s Appraisal Review Scheme.
Desirable
Registered as a healthcare professional
At least one years’ experience gained in Medical Information
Gained experience in a Pharmacovigilance environment.
In return, we offer a range of company benefits and support ongoing CPD.
If you wish to be considered for less than full time hours, please state clearly your requirements in your application.
Please send your cv and cover letter and proof of right to live and work in the UK by attaching a scanned copy of the relevant page from your passport or any other official document to deepa.patel@redlinepv.co.uk by Friday 9 August 2024.
You must also provide proof of address as a supporting document to confirm that you live within the MK or one of the bordering counties as this is an office-based role.