- Permanent, Full Time
- Closes 6th June 2018
- Requisition ID: WD166431
In this job your role will span the work of project and product safety as practiced by Directors in both the GCSP SERM: Development and GCSP SERM: Mature Products groups. Your roles and responsibilities described herein will be performed in partnership with the SDL for assigned products, if an SDL is assigned, as appropriate.
• Provide scientific expertise in the safety evaluation and risk management of key GSK assets or other highly complex products in clinical development and/or the post-marketing setting
•Ensure that adverse event and other safety information is evaluated in order to meet global compliance and regulatory requirements,
• Identify the need for product labelling updates and drive proactive implementation of risk management initiatives
• Safety Governance and Risk Management activities
• Drive pharmacovigilance and risk management planning in the clinical matrix
• Lead production of global Benefit-Risk Management Plans for designated products
• Lead safety input into regulatory benefit-risk assessments
• Prepare the regional Risk Management Plans for designated products for submission to regulatory authorities
• Deliver the clinical safety input into clinical development planning activities
• Represent GCSP on cross functional Clinical Matrix Teams and/or Project Teams.
• Lead cross-functional ad hoc teams to address urgent and important product safety issues
• Review and provide technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters
• May lead or participate in discussion at Global Safety Board / Consumer Products Safety Board for safety related findings in clinical development.
• Present safety information at clinical investigator and commercial meetings.
• Ensure prompt notification to SERM Head of reviewed protocols that are identified as potential PASS
• Establish and chair the Safety Review Team (SRT) for projects in development
• Provide expert review of data and management of safety issues.
• Escalate safety signals identified through the Safety Review Process to Global Safety Board / Consumer Products Safety Board if necessary, via the SERM Head.
• Ensure that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate
• Signal Detection, Evaluation and Labelling
• Drive signal detection for assigned products using available methodologies (including On-Line Signal Management tool, literature review and tools for individual case awareness).
• Make recommendations to SERM Team Leader for the assessment and prioritisation of safety signals
• Proactively lead the assessment of safety data and discuss the results with the SERM Team Leader/ product physician.
• Communicate with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations
• Lead presentations on labelling recommendations at Global Labelling Committee / Consumer Healthcare Global Labelling Committee or Global Safety Board / Consumer Products Safety Board
• Produce regulatory supporting documentation for labelling updates
• Produce accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data.
• Provide strategic input into regulatory requests for local label deviations from the company core data sheet
• Conduct proactive signal detection and evaluation of issues potentially related to product defects or manufacturing issues;
• Drive the escalation and resolution of issues and product complaints In consultation with the product physician and Clinical Development
• Represen, prepare the Development Core Safety Information (DCSI) for assigned development products;
• Co-ordinate and chair meetings and track timelines to ensure completion of Regulatory Reports and Submissions
• Drive production of periodic regulatory documents (PSURs, DSURs) according to the agreed process and timelines.
• Advise on strategy for the content of high profile PSURs
• Support the Local Operating Companies by preparing license renewal documentation (e.g. PSUR addenda line listings, clinical overviews, summary bridging reports) as required for each market
• Lead the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
• Drive the review or production of the SERM component of Safety Data Exchange Agreements and escalate any deficiencies to the SERM Head to ensure quality and integrity of agreement.
• Advise on the preparation of licensing agreements in therapeutic area of responsibility
• Participate in due diligence activities by providing expert safety assessments and recommendation
• Participate in GSK internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities
• Provide support to GSK Legal for product liability litigation, as appropriate
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
• Lead a process improvement initiative within GCSP.
• Contribute to advancement of methodology and process by generating new ideas and proposals for implementation
• Raise concerns/ issues (i.e. sentinel events) to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated
• Train, coache and mentor scientists in the scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents
Because, You have:
• A degree in Biomedical or Health Care related speciality
• Expert in evaluation and analytical thinking skills
• Medical writing skills
• Computing skills
• Knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities
• Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education
• Understanding of clinical development process
• Have a proven ability to lead safety evaluation activities,
• Ensure that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes
• Show confidence, credibility and influence at all levels of the organisation
• Present the disease area or product area safety strategy at key internal GSK meetings and
• Represent GSK externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
• Early phase Oncology/product experience
• Knowledge of the therapeutic area of assigned GSK products
• Knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at the population level
• Knowledge of medical and drug terminology and a foundation in pharmacology
* LI GSK
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.