Drug Safety Administrator

Our client is a market leader within the Pharma Covigilance market. They are looking to recruit a Drug Safety Administrator who will be an active participant in meetings and assist the PV Manager in maintaining standard operating procedures or working practices. During their daily activities, the Drug Safety Administrator will be required to liaise with pharmaceutical companies and other business partners.

Daily tasks:

• Keeping the Pharmacovigilance Manager fully informed of problems and issues that may arise related to the product, adverse events, the patients, prescribers or the marketing authorisation holder.
• Processing selected case reports in the database.
• Checking all literature case reports have the appropriate AE terms assigned for MedDRA coding. Notifying the QPPV of cases where the appropriate MedDRA term cannot be identified independently.
• Reconciliation both with clients and/or with PV partners on behalf of clients (as required).
• Processing reports from any source in the drug safety database.
• Assessing adverse events and carry out listedness and causality assessments.
• Exchanging a PV case reference from the database with PV partners.
• Conducting follow-up investigation for direct reports from either patients or healthcare professionals.
• Maintaining Continued Professional Development in support of your role and responsibilities.
• Participate in various team meetings and liaise with other colleagues about on-going projects.
• Assist with documentation such as Working Practices and Standard Operating Procedures, where required.
• Develop a thorough knowledge of medicinal products and with regulations and guidelines within the industry.
• An organised, proactive person with excellent attention to detail.
• Excellent oral and written communication with proficiency in standard software programs.

Minimum Requirements:

• Life science or Bio medical graduate (1-2 years working experience desirable) or other allied healthcare professional.

Please note candidates will only be considered with the above skills and unfortunately this company cannot consider sponsorship, or a visa status that will need renewing.