Clinical Scientist, Global Collaborative Studies, Open to flexible working
The primary focus of this role is to handle activities relating to: the provision of safety, risk mitigation and pharmacovigilance (PV) support for the use of ViiV Healthcare (VH) assets in VH supported studies (investigator sponsored studies (ISS), and supported collaborative studies (SCS) conducted with partner organisations); and the fulfilment of VH safety data exchange requirements as part of the legal agreements for these studies.
This is to enable Sponsors to adequately safeguard study participants from the key side effects with VH medications; and enable VH to meet regulatory obligations as product owner and license holder, such as signal detection and management.
In addition, this role will also support more general ISS and SCS activities including specific study accountabilities and management.
- Run safety, risk mitigation and PV related activities and processes for VH supported studies including: update and maintenance of applicable SOPs/Policies, guidance documents and study proposal, protocol, ICF and legal agreement safety review processes (ViSiONS review forms and workflows); development and implementation of safety training for relevant partners; oversight and support of Study Accountable Persons (SAPs) safety accountabilities during study conduct; input to legal agreement safety data exchange clauses; consulting on impact of PV legislation; implementation and conduct of new quarterly and annual management monitoring and other tracking activities; and overall process improvement.
- Support Regional ISS and SCS activities and meetings; provide support to Regional ISS Leads and local SAPs to ensure studies are progressed in a timely manner and data are delivered with an appropriate sense of urgency through timely resolution of study issues consistent with relevant policies and procedures.
- Study Accountable Person (SAP)- driving all aspects of review, implementation and conduct from contracting, Sponsor study team membership, investigator/Sponsor interactions, study milestone / budget and/or drug supply management, study documentation review, through to data disclosure.
- Cross functional working with key internal partners; understand and maintain relationships and activities to ensure timely, compliant and efficient delivery of ViiV support for ISS and SCS, end-to-end (e.g., GSK and ViiV Safety & PV, Legal, Drug Supplies, Regulatory, Publications, Regions/LOCs)
- Quarterly contributions of data on the ISS and SCS programme to advise product specific Global Integrated Evidence Plans (IEPs)
- 3 years or more experience in the pharmaceutical industry in a clinical research /medical role
- BSc (Hons) in Biology, Clinical or Medical Science or equivalent health care-related specialty
- Master's degree or PhD would be preferred
- Pharmacovigilance experience relating to clinical safety reporting/data exchange and risk management
- Experience of the clinical development process (from Phase 1 to Phase IV), especially related to clinical trial operations
- Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
- Ability to assimilate, interpret and disseminate sophisticated scientific and medical concepts and information
- Self-motivated, highly organised and have experience co-ordinating multiple projects
- Ability to work effectively in a team and matrix environment, with proven track record to influence and negotiate with internal partners at all levels in the company
- Ability to establish and maintain mutually encouraging external/customer facing relationships
- Excellent technical writing skills, high degree of accuracy with attention to detail.
- Solution focussed with proven track record to solve sophisticated problems and identify process improvements Computer literate, able to become familiar with new systems and software easily
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