Medical Director
- London, England (GBR)
- £170 - £175 Per Hour
- 12 Months
- Start date: ASAP
- Ref: GSK0JP00012345
- clinical safety
- medical writing
- protocols
- healthcare
- hiv
- aggregate
- case management
- therapeutic
- data monitoring
- risk management
Medical Director – ViiV Paediatrics
Safety/Pharmacovigilance Physician - Clinical Development
GSK House - Brentford
12 months
£170-£175 per hour via Umbrella
-We are seeking an experienced contract Safety Physician to work in the Specialty Safety Evaluation and Risk Management (SERM) Group. Global Safety is responsible for the collection, processing and regulatory reporting of adverse events experienced by patients receiving GSK products, and for the ongoing safety evaluation and risk management of all GSK products (marketed or developmental). This contract Safety Physician role within GSK is specifically aligned to provide safety support and expertise to ViiV Healthcare (www.viivhealthcare.com) which specialises in HIV treatment, prevention and care.
-We are looking for a safety/pharmacovigilance physician with in-depth and hands-on experience in clinical development, proven matrix team leadership and strong communication skills. We are seeking an experienced safety Physician who can contribute to the advanced benefit-risk management of the ViiV portfolio.
In this role, you will provide high level pharmacovigilance expertise to new and cutting-edge medicines in clinical development with a focus on paediatrics and antiretrovirals. You will ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements.
-You will have a proven ability to lead safety evaluation activities, ensuring that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes.
-GSK and ViiV consider the safety of patients and study participants using their products to be of paramount importance.
RESPONSIBILITIES:
Safety Governance and Risk Management activities
– Delivers the safety input into clinical development planning activities
– Reviews and provides technical approval (as appropriate) for investigator brochures, protocols, informed consent forms, clinical study reports, and external data monitoring committee charters
– Leads or participates in discussions at ViiV Governance Boards on safety related findings in clinical development
– Represents Global Safety on cross functional clinical matrix teams and/or project teams. Leads cross-functional teams to address urgent and important product safety issues
– Leads or contributes to the Safety Review Team for assigned project(s) and provides expert review of data and management of safety issues. Escalates safety issues identified through the Safety Review Process to the relevant ViiV stakeholders. Accountable for ensuring that risk mitigation strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate
– For designated products, drives pharmacovigilance and risk management planning in the clinical matrix and leads production and updating of Risk Management Plans
Signal Detection, Evaluation and Labelling
– May have overall responsibility for the conduct of the signal detection and evaluation process for assigned products. Drives signal detection for assigned products using available methodologies, including aggregate data review, literature review and tools for individual case awareness. Makes recommendations to ViiV senior stakeholders for the assessment and prioritisation of safety signals
– Provides expertise to signal detection and assessment for designated products in partnership with other team members, including medical expertise if a physician
– Proactively leads the assessment of safety data and discusses the results with the ViiV senior stakeholders. Effectively communicates with Clinical Development and other key stakeholders on signal evaluation recommendations
– If a physician, may provide medical sign-off for regulatory documentation
– Produces accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data
– Conducts proactive signal detection and evaluation of issues potentially related to product defects or manufacturing issues; drives the escalation and resolution of issues and product complaints. Supports production of quality incident Medical Assessments and Dear Investigator letters
– In consultation with team members and Clinical Development representatives prepares the Development Core Safety Information for assigned development products; including coordinating meetings and tracking timelines to ensure completion
Regulatory Reports and Submissions
– Drives production of periodic regulatory documents (DSURs, Annual Reports) according to the agreed processes and timelines
Other SERM Activities
– Contributes to the review of Safety Data Exchange Agreements and escalates any deficiencies to the relevant stakeholders to ensure quality and integrity of agreement. Advises on the preparation of licensing agreements in therapeutic area of responsibility
– Participates in due diligence activities by providing expert safety assessments and recommendations
– Provides support to ViiV Legal for product liability litigation, as appropriate
– Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
– May participate in, or leads, cross-GSK activities such as safety advisory panels, task forces or scientific forums
– Raises concerns/issues to senior stakeholders in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated
– May provide medical safety support for the Case Management function. Reviews and approves safety reports to investigators in partnership with the Clinical Development physician
– May provide input to, or participate in, meetings of an independent data monitoring committee
(IDMC) or internal safety review committee (iSRC)
Experience and Qualifications
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
– Medical Degree (i.e. clinician/physician/medical practitioner)
– Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities
– Good medical judgement and ability to make medical decisions
– In depth knowledge of clinical development process
– Industry experience – especially multi-function experience e.g. clinical safety + clinical development
– Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies
– Expert evaluation skills and analytical thinking
– Outstanding medical writing skills
– Sound computing skills
Preferred Qualifications
If you have the following characteristics, it would be a plus:
– Experience and background in HIV
– Experience and background in paediatrics
