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 2) to join our dedicated Pharmacovigilance team.

The focus of this role:

• Responsible for day-to-day operations of pharmacovigilance department.
• Exercises high level of independent decision making.
• Delivers tasks and initiatives with minimal guidance from senior colleagues.
• Follows established procedures and company processes

As this role includes working from home we will 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.

KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:

• Life science related degree (required)
• Minimum of 2 years of Drug Safety experience or related (required)
• Case processing experience (required)
• Expedited (SUSAR) reporting experience (required)
• Prior experience of working with MHRA, EudraVigilance and/or XEVMPD user certification (preferred)
• Experience with the use of safety databases (eg ARISg, Argus)

RESPONSIBILITIES:

• Contributing to the preparation and implementation of study specific Safety Management Plans (SMPs) and delivering training to junior colleagues and other study team members.
• 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/AESIs/SUSARs, 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.
• Contributing to the development of documents related to safety (e.g. SOPs, safety section of protocols, etc.).
• Coordinating the review of safety data by the Medical Monitors at pre-determined intervals.
• Participating actively in Pharmacovigilance team meetings.
• Participating in signal detection, trends and patterns recognition activities, as appropriate.
• Providing after-hours monitoring and processing of SAE reports, if required by sponsors
• Ensuing audit preparedness and support regulatory inspections in relation to PV
• Maintaining up-to-date knowledge of protocol and scope of work for assigned projects.
• Providing support for new staff training, audit and inspection
• Writing and updating PV SOPs

The focus of this role:

• Responsible for day-to-day operations of pharmacovigilance department.
• Exercises high level of independent decision making.
• Delivers tasks and initiatives with minimal guidance from senior colleagues.
• Follows established procedures and company processe