Safety Scientist

ROLE SUMMARY: Responsible for the continued safety assessment, evaluation and risk management of major GSK products or product groups in clinical development and/or the post-marketing setting

Ensures that adverse event and other safety information is efficiently 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

Provides significant and proactive clinical safety input on cross-functional teams (including Safety Review Teams) and ensures that appropriate safety objectives and risk minimisation strategies are included in clinical development programs

RESPONSIBILITIES:

Safety Governance and Risk Management activities

• Conducts, or leads with guidance, pharmacovigilance and risk management planning for designated products, including preparation of global Benefit-Risk Management Plans, in partnership with the product physician Contributes to regulatory benefit-risk assessments and prepares the regional Risk Management Plans for designated products
• In partnership with the product physician, provides the clinical safety input into Clinical Development planning activities
• Represents GCSP on cross-functional Clinical Matrix Teams and/or Project Teams for developmental compounds. Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues
• Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters. May present safety information at clinical investigator and commercial meetings. Ensures prompt notification to TA Head of reviewed protocols that are identified as potential PASS
• Facilitates establishment of Safety Review Teams as necessary, provides data for review and actively contributes to interpretation and discussion. May chair a Safety Review Team with guidance. Ensures that risk-reduction strategies are implemented appropriately in relevant documents such as clinical study protocols and/or product labelling

Signal Detection, Evaluation and Labelling

• Runs routine signal detection process (including On-Line Signal Management Tool, literature review and, in partnership with product physician, tools for individual case awareness) for all products in area or responsibility. Proactively proposes and discusses priority for reviews with the SERM TA Director/product physician; communicates, escalates and documents outcome of signal detection process
• Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals. Takes the lead role in data evaluation and discusses the results with the SERM TA Director/product physician and other key stakeholders (e.g. Clinical Development groups)
• Presents on labelling recommendations for complex issues to GSK Global Labelling Committee or Global Safety Board, in partnership with product physician
• Produces regulatory supporting documentation for labelling updates
• Produces accurate and fit for purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data. Provides strategic input into regulatory requests for local label deviations from the company core data sheet, in partnership with the product physician
• Routinely monitors safety issues potentially related to a product defect and/or manufacturing issue; communicates with the product physician/ TA Director and/or Manufacturing; documents outcome
• In consultation with the product physician and Clinical Development representatives, prepares the Developmental Core Safety Information (DCSI) for assigned development products; co-ordinates meetings and tracks timelines to ensure completion
  

Regulatory Reports and Submissions

Authors periodic regulatory documents (PSURs, Annual Reports) according to the agreed process and timelines. Co-ordinates the compilation of large PSURs requiring a GCSP team approach and provides high-level summaries on major issues.

Supports 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

Authors the SERM safety contribution to global regulatory submissions for new products, formulations or indications, in partnership with the product physician and liaison with other functional experts (e.g. Clinical Development, regulatory)

Other SERM Activities

• Contributes to and/or reviews the SERM component of Safety Data Exchange Agreements, and escalates any deficiencies to the SERM TA Director to ensure quality and integrity of agreement. Advises on the preparation of licensing agreements in therapeutic area of responsibility
• Participates (along with SERM product physician) in GSK internal meetings with project focus. Participates in external non-regulatory meetings including those with consultants and other companies such as licensing partners
• May assist in due diligence activities in collaboration with more senior staff May provide support to GSK Legal for product liability litigation, as appropriate
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
• Participates in, and may lead, a process improvement initiative team within GCSP. May contribute to advancement of methodology and process by generating new ideas and proposals for implementation.
• Raises 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
• May mentor and train more junior scientists in signal evaluation methodology, risk management and preparation of safety reports and other documents

EDUCATION, KNOWLEDGE AND TECHNICAL EXPERIENCE

• Bachelors, or above, degree in Biomedical or Health Care related speciality
• Advanced evaluation skills and analytical thinking for scientific literature review, data gathering, data synthesis, analysis and interpretation
• Strong medical/scientific writing skills
• Sound computing skills
• In depth knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities. In depth understanding and experience of causality assessment, evaluation of safety signals and of proactive risk management strategies, including management of labelling changes, physician and patient education and monitoring of safety issues
• Sound knowledge of therapy areas of assigned products
• Knowledge of other relevant disciplines (e.g. statistics, pharmacoepidemiology and associated methodologies) pertinent to assessing drug utilization and safety at the population level
• Sound knowledge of medical and drug terminology
• Clear understanding of drug development process and the drug approval process in major countries

CORE BEHAVIOURAL COMPETENCIES:

• Makes sound decisions in complex situations based on relevant information or factors gathered from broad range of sources, seeking input as needed. Identifies, evaluates, and recommends solutions, to problems.
• Builds strong working relationships and demonstrates good matrix leadership skills. Able to train, coach and mentor others
• Skill to manage and co-ordinate tasks and projects
• Highly effective communication skills
• Effective negotiating, influencing and persuasion skills
• Able to prioritise activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality
• Demonstrates initiative and creativity in performing tasks and responsibilities. Proactively contributes ideas to improve existing operations
• Able and willing to adjust behaviours and priorities based on changing environment. Able to deal with ambiguity and resilient, focused and optimistic under pressure
• Takes account of the internal and external environment when considering safety issues Able to contribute to the matrix with confidence, impact, integrity and professionalism

Join GSK’s vision to do more, feel better and live longer:

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Who will I be working with?

http://www.gsk.com/en-gb/careers/meet-our-people/

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