Drug Safety Assistant

Job Title: Drug Safety Assistant
Job Location: High Wycombe , UK
Job Duration: 12 Months

Execute drug safety support activities as required for Marketing Authorisation Holders (MAH’s) and/or study sponsor, as applicable to ensure client complies with Good Pharmacovigilance Practice regulation.

PRINCIPAL RESPONSIBILITIES:
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 TFUP 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
•Administers 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
•Files maintains and archives all case materials, including original source documentation
•Support CSTL / LSO in responding to ad hoc requests as required 40

WORKING RELATIONSHIPS/INTERFACES:
External relationships:
•All third party partners
•Competent Authorities/Regulatory Bodies: MHRA (Medicines and Healthcare products Regulatory Agency), IMB (Irish Medicines Board), British Standards Institution (BSI)
•Patients and healthcare professionals
Internal relationships:
Provision of information / acknowledgement of receipt of information / requests for additional information (as appropriate) on a daily, weekly or monthly basis to:
•Global Medical Safety
•Pharmaceutical affiliates: LSOs at other LOCs, McNeil/Pharmaceutical Consumer, Crucell
•Janssen Medical (Regulatory Affairs, Medical Information, Market Research, Outcomes Research, Sales, Quality Assurance)
•Site Managers/Local Trial Managers/Global Trial Managers responsible for company sponsored and or investigator-sponsored clinical trials
•Any and all staff members of Janssen UK and Ireland

EDUCATION & EXPERIENCE REQUIREMENTS:
Essential Knowledge & Skills
•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

RELATED EXPERIENCE:
0-2 years

OTHER COMMENTS:
Fluency in English language required.
Occasionally flexible working hours

To apply for this job please visit www.reed.co.uk.

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