Medical Director- SERM
Site Name: USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Upper Providence
Posted Date: Sep 24 2019
Do you want to play a key role in supporting the Central Safety Leadership Team and the broader business at both a strategic and operational level? If so, this role is perfect for you.
- ROLE SUMMARY:
- Provides high level medical expertise in the safety evaluation and risk management of key GSKassets or other highly complex products 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
- Has a proven ability to lead safety evaluation activities, ensures that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes and shows confidence, credibility and influence at all levels of the organisation
- Presents the disease area or product area safety strategy at key internal GSK meetings and represents GSK externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
- Accountable for medical review and sign-off for regulatory documents, including Periodic Benefit: Risk Evaluation Report (PBRERs)
Safety Governance and Risk Management activities
- Drives pharmacovigilance and risk management planning in the clinical matrix and leads production of global Benefit- Risk Management Plans for designated products
- Leads safety input into regulatory benefit-risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authorities
- Delivers the clinical safety input into clinical development planning activities
- Represents SMG on cross functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc
- teams to address urgent and important product safety issues
- Reviews and provides 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 for safety related findings in clinical development.
- Presents safety information at clinical investigator and commercial meetings.
- Ensures prompt notification to Group Leader or above of reviewed protocols that are identified as potential PASS
- Establishes and chairs the Safety Review Team (SRT) for projects in development and provides expert review of data and management of safety issues.
- Escalates safety signals identified through the Safety Review Process to Global Safety Board if necessary, via the Group Leader or above.
- Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate
- Provides medical expertise for risk evaluation and risk management planning
Signal Detection, Evaluation and Labelling
- Drives signal detection for assigned products using available methodologies (including On-Line Signal Management tool, literature review and tools for individual case awareness).
- Makes recommendations to Pharma Safety Group Leader or above for the assessment and prioritisation of safety signals
- Provides medical expertise to signal detection and subsequent evaluation for designated products in partnership with the responsible safety scientist
- Proactively leads the assessment of safety data and discusses the results with the Pharma Safety Group Leader or above and product scientist.
- Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations
- Leads presentations on labelling recommendations at Global Labelling Committee or Global Safety Board
- 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
- Provides medical sign-off for regulatory documentation and represents SMG as the medical member of labelling discussions
- 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
- In consultation with the product scientist and Clinical Development representatives, prepares the Development Core Safety Information (DCSI) for assigned development products
- Co-ordinates and chairs meetings and tracks timelines to ensure completion
Regulatory Reports and Submissions
- Drives production of periodic regulatory documents (PBRERs, Annual Reports) according to the agreed process and timelines.
- Advises on strategy for the content of high profile PBRERs
- Supports the Local Operating Companies by preparing license renewal documentation (e.g. PBRER addenda line listings, clinical overviews, summary bridging reports) as required for each market
- Accountable for medical input, review and sign-off of periodic reports (e.g. PBRERs) and renewal documentation submitted to regulatory agencies
- Leads the Pharma Safety safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
Other Pharma Safety Activities
- Drives the review or production of the Pharma Safety component of Safety Data Exchange Agreements and escalates any deficiencies to the Pharma Safety Group Leader or above 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
- Participates in GSK internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities
- Provides support to GSK Legal for product liability litigation, as appropriate
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
- Leads a process improvement initiative within SMG.
- Contributes 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
- Trains, coaches and mentors scientists in the medical/scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents
- May provide medical safety support for the US and RoW Case Management functions.
- 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
- GSK internal safety review committee (iSRC)
- Physician (M.D. or equivalent) ideally with board certification in Internal Medicine, Family Medicine, Emergency Medicine or Surgery. Subspecialty training/certification is a plus. Active or eligibility for a US Medical license is required.
- Expert evaluation skills and analytical thinking
- Outstanding medical writing skills
- Sound computing skills
- Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to Pharma Safety activities
- Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education
- Sound knowledge of the therapeutic area of assigned GSK products
- Sound knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at the population level
- In depth knowledge of medical and drug terminology and a sound foundation in pharmacology. Good medical judgement and ability to make medical decisions
- Clear understanding of clinical development process
- Clear understanding of drug approval process in major countries
- Previous experience in pharmaceutical industry and drug development pharmacovigilance preferred
- Previous experience in clinical practice or academics preferred
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Demonstrated track record of quality decision making and problem resolution based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context
- Excellent leadership skills in the matrix team setting.
- Proven ability to train, coach and mentor
- Ability to manage and co-ordinate tasks, projects and processes across a large organisation
- Highly effective communication skills; able to present complex data to groups at all levels of the organisation and externally to GSK.
- Makes medical information/concepts accessible for non-physicians
- Highly developed negotiating and influencing skills. Ability to influence others to make sound decisions from a medical point of view by providing clear medical information
- Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality
- Contributes innovative ideas to address new issues or improve approaches to existing operations Ability to adjust behaviours and priorities based on changing environment
- Demonstrated ability to think tactically and strategically and take account of internal/external environment when considering safety issues and business processes
- Ability to engage in, and contribute to, broad GSK environment with confidence, impact, integrity and professionalism
This is a job description to aide in the job posting, but does not include all job evaluation details.
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