Medical Monitor/Safety Physician

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.

Qualifications 

• Medical doctor degree 
• 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. 

• Health Insurance
• Free onsite parking
• Eye care vouchers
• 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 [email protected] 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.