Hobson Prior is currently recruiting a PV Safety Specialist job position, which has opened up at an international contract research organisation providing drug discovery, lifecycle management and laboratory services. With offices in over 45 countries and approximately 13,000 professionals, this company provide innovative ideas behind multiple sectors. This particular position will be based in the UK on a contract basis.
- Performs day-to-day adverse event reporting and subsequent Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines.
- Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information.
- Coordinates and performs adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities.
- Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third-party vendors.
- May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.
- Works independently to receive, triage, manage, and reconcile adverse event reports, including those reported in the scientific literature, in accordance with contractual and regulatory timelines.
- Manages adverse events and endpoints which may include review of complex medical records, preparation of adverse event narratives and coding of event terms utilizing MedDRA. Assigns preliminary seriousness and labeledness/listedness of event(s).
- Works within multiple databases.
- May interact with clients, health care professionals, clinical trial personnel and consumers.
- Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
- General understanding of pathophysiology and the disease process
- Detailed knowledge of relevant therapeutic areas as required for processing AEs
- Strong critical thinking and problem-solving skills
- Good oral and written communication skills including paraphrasing skills
- Good command of English and ability to translate information into local language where required
- Computer literate with the ability to work within multiple databases
- Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)
- Understanding the importance of and compliance with procedural documents and regulations
- Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
- Strong attention to detail
- Ability to maintain a positive and professional demeanour in challenging circumstances
- Ability to work effectively within a team to attain a shared goal
- Bachelor’s degree in Nursing, Medical Technology or Pharmacy plus 2 years of clinical experience
- Or Life Science degree with a minimum of 2 years of clinical experience and 1-year pharmacovigilance experience
- Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the job
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life science recruiter focussed on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.