Pharmacovigilance Associate (Level 1)

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 seeking to appoint a Pharmacovigilance Associate (Level 1) to join our dedicated Pharmacovigilance team.

The focus of this role is to:

• Responsible for day-to-day operations of pharmacovigilance department ensuring compliance with established procedures and company policies. 
• To perform tasks and initiatives with some guidance from senior colleagues/Senior PV Associate

As this role includes working from home we will therefore 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), by submitting your application you are confirming you are able to do this. 

• Life science related degree (essential)
• 1-2 years of Drug Safety experience or related within CRO or pharmacy (essential)
• Case processing experience (preferred)
• SAE and SUSAR experience (preferred)
• Experience with the use of safety databases eg ARISg, Argus (preferred)
• Ability to exercise a moderate level of independent decision making (essential)

RESPONSIBILITIES:

• Implementing Safety Management Plans (SMPs) specific for the study protocol and Sponsor requirements.
• Managing the receipt and processing of SAE reports according to the Safety Management Plan, or equivalent document.
• Notifying the Sponsor and clinical team of SAEs, as required.
• Preparing safety reports for Sponsor approval, regulatory submission and investigator notification.
• Submitting safety reports to regulatory agencies, Central Ethics Committees and Investigators, as required.
• Maintaining study-specific records for SAEs and safety reports, including the safety database.
• Reconciling the Safety and clinical databases and coordinate with data management and Clinical Research Associates to resolve discrepancies.
• Coordinating the review of safety data by the Medical Monitors at pre-determined intervals.
• Participating actively in Pharmacovigilance team meetings.
• Providing after-hours monitoring and processing of SAE reports, if required by sponsors

• 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 [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.