Lucy Stendall is recruiting for two Drug Safety Associate's to join a leading medical device company at their site based in High Wycombe on a contract basis for 6 months initially.
The Drug Safety Associate will be responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.
The main purpose of the role will be:
- Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness
- Triage of incoming cases to prioritise for daily workflow management
- Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval
- Preparation of SUA summary: Analysis of Similar Events
- Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
- Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
- Completion of all assigned training on company and GMSO procedural documents relating to case processing
- Completion of training relating to relevant PV Agreements for assigned products
- Participate in designated activities to support revision/creation of case processing procedural documents
- Participation in local or global project teams, including on-time delivery of assigned responsibilities
- Participation in inspections and audits as identified, including interviews and provision of requested data
- Personal development: continuous development of personal skills whether task or competency-related. Activities may include project involvement, technical training, shadowing and/or mentoring others, soft-skill development.
- Mentoring of other DSAs or staff, as identified
- Maintains compliance with company guidelines and HR Policies
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Registered Nurse or Pharmacist
- Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
- Licensed Practical Nurse with Bachelors degree, or with knowledge of pharmacovigilance usually exhibited by previous experience in pharmaceutical safety-related role
- Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas. Case processing experience is desired
- Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
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 KA41995 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 25th April 2018
- Expires: 23rd May 2018
- Reference: KA41955