Medical Monitor/Safety Physician

MAC Clinical Research; Manchester; Remote; GBP 60,000 - 80,000; Full time

Job summary

Join a leading global Contract Research Organisation as a Medical Monitor/Safety Physician. This home-based role involves overseeing safety issues in clinical trials, requiring strong analytical skills and experience in drug safety. You will work closely with teams to ensure compliance and manage safety data effectively, contributing significantly to human health.

Benefits

Health Insurance

Free onsite parking

25 days annual leave

Your birthday off work

Qualifications

• Minimum of 2 years’ experience as a medical monitor.
• Experience in clinical development in pharma or CRO.

Responsibilities

• Managing day-to-day study-related safety issues.
• Review and assess Serious Adverse Events and safety data.
• Conduct periodic aggregate safety data reviews.

Skills

Analytical and critical thinking

Effective communication

Interpersonal skills

Problem-solving

Detail-oriented

Education

Post graduate qualification such as DPM, PMST

Tools

MS Office

Job description

Join to apply for the Medical Monitor/Safety Physician role at MAC Clinical Research

Join to apply for the Medical Monitor/Safety Physician role at MAC Clinical Research

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MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.

We are now looking for an experienced Medical Monitor/Safety Physician to join our growing CRO team! This is an exciting opportunity to work on projects with sponsor companies in our expanding and dynamic Medical Monitoring Department.

This role is home based and therefore we require you to have a set up at home that allows you to work comfortably. This includes an appropriate desk and chair (excl. IT equipment which we will provide). You are confirming you are able to do this by proceeding with your application.

There will be a requirement for some travel to our site in Greater Manchester, this will be dependent on business needs, and we expect that once every couple of months will be the average amount of time needed on site.

Requirements:

Qualifications

• Minimum of 2 years’ prior experience as a practicing medical monitor in pharmaceutical industry (Essential)
• Minimum of 2 years’ prior experience working in clinical development/ clinical trials in pharma or CRO (Essential)
• Experience in industry as Drug Safety/Pharmacovigilance Physician (Desirable)
• Post graduate qualification such as DPM, PMST (Desirable)

Skills

• Deep knowledge of GCP including a good understanding of regulatory requirements/ drug safety / GVP.
• Analytical and critical thinking skills.
• Effective communication and interpersonal skills
• Ability to work in a cross-functional team environment.
• Experience in protocol development and clinical trial management.
• Full working proficiency in English.
• Proficiency with MS Office applications.
• Communication, presentation, and analytical skills.
• Problem-solving, team and detail-oriented.

Responsibilities

• Managing day to day study related safety issues
• Review and assess Serious Adverse Events (SAEs), SUSARs, pregnancy reports and other safety data from ongoing studies and unblinding for medical emergencies as required.
• Conduct periodic aggregate safety data reviews to identify potential safety signals.
• Conducting study or disease-specific safety training to study team as required.
• Draft initial study specific medical monitoring plan and study specific safety management plan with sponsor and revise as required.
• Provide medical oversight on study related safety issues including eligibility review (as required), medical questions from site/project team (as required), review of protocol deviations from site/project team, and medical monitoring safety report (as required).
• Review of safety data in the study EDC system and lab portal to allow for real time observation.
• Review of draft/final: Clinical Study Report (CSR).
• Out of Hours medical coverage (24/7 coverage for urgent safety issues).
• To maintain professional qualifications required for the role, including continuous personal development.
• Ensure adherence to global pharmacovigilance regulations (ICH, FDA, EMA, GCP). Participate in audits, inspections, and preparation of responses to health authority queries.
• To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure your job role is efficiently carried out.

BENEFITS:

• Health Insurance
• Free onsite parking
• 25 days annual leave (increasing in increments to 30 days after 6 years' service)
• Your birthday off work

MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.

Please email [e-mail] should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Health Care Provider, Research, and Science

• Industries

  Research Services, Medical Practices, and Health and Human Services

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