Milton Keynes, England, £27,000 - £28,000, full time, dependant on experience.

The successful candidate will be responsible for participating in the collection, safety review, processing and reporting of adverse event data in compliance with applicable local and global regulations and company standard operating procedures.

They will perform accurate computer data entry of identified adverse event information, ensure timely processing and where necessary report these to regulatory authorities. The Drug Safety Administrator 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.

Pharmacovigilance key 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.
• Upload ProQuest alerts for assigned active ingredients into the Literature Monitoring System (LMS). Identifying case reports and important safety information/published studies in the LMS database.
• Processing selected case reports in the ICSR 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 ICSR 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 ICSR 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.
• A person with a professional, friendly and polite demeanour.
• An organised, proactive person with excellent attention to detail.
• Excellent oral and written communication with proficiency in standard software programs.
• Someone who is willing to learn and improve his or her knowledge on a continuous basis.

Minimum Requirements:

• Life science graduate (1-2 years working experience desirable) or other allied healthcare professional.
• Someone who can work alone, plan and prioritise his or her assignments under strict timelines.