Heather Deagle at CK Group is recruiting for a part-time Drug Safety Assistant to join a company in the Pharmaceutical industry at their site based in High Wycombe on a 6 month contract basis. The working hours for this role are two days a week (14.8 hours).

The Company:
Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies - the largest diversified healthcare group in the world with over 100 years of scientific heritage. They employ approximately 500 people in the UK and Ireland. They are committed to delivering great medicines and have introduced a range of innovative treatments that can make an important difference to the lives of patients with serious health conditions such as schizophrenia, hepatitis C, multiple myeloma, HIV/AIDS and diabetes.

The Location:
Working at their Headquarters in High Wycombe, the site is easily commutable. The nearest station is approximately 10 minutes by taxi. If you're travelling by car you can access the site via the M40.

The Role:
Responsible for supporting the coordination of safety reporting requirements as required for Marketing Authorisation Holders (MAHs) and /or study sponsor, as applicable.

Key Duties include:
Call Handling:
- Answer inbound calls from general public, HCPs, internal colleagues to elicit and capture relevant adverse event data.

Case Processing:
- Enter relevant/required safety data into the Global Safety Database from various sources.
- Request additional information from multiple sources, both internal and external to the company.

Reconciliation:
- Confirm that requests for additional follow-up has been sent to reporters as appropriate through review of due diligence reconciliation reports and monitoring that due inbox.
- Support questionnaire reconciliation.
- Monitor due diligence schedule process.
- Clinical scan and attach files into sceptre.

Compliance Activities:
- Review case files and/or processes as directed to support internal and external audits and inspections.
- Complete all assigned training in a timely manner.
- Administer the due diligence process to ensure completeness of case reports and timely distribution of follow-up requests.
- Managing post.
- Letter writing.
- Loose filing and IRT processing.
- File, maintain and archive all case materials, including original source documentation.
- Support in responding to ad hoc requests as required.

Your Background:
To be considered for the role you should have the following skills, knowledge and experience:
Essential
- Awareness of and familiarity with medical terminology.
- Proficiency in global and local SOPs.
- Computer literate with expert knowledge of the Global Safety Database.
- Ability to prioritise and work to strict timelines on a daily basis.
- Excellent verbal and written communication skills.
- Ability to communicate with internal and external customers.
- Ability to work effectively as a member of the Drug Safety and broader Medical Department teams.

Experience
- Previous experience in a similar/related role is desirable.

Education
- Degree-level qualification (ideally in life science) or equivalent qualification.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45329 in all correspondence.