Job Description

• Please note - an external finalist has been identified for this opportunity *

The SERM Director, Safety Scientist provides high level scientific expertise in the safety evaluation and risk management of key GSK assets or other highly complex products in clinical development and/or the postmarketing setting. The Director will ensure 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. They will 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. The Director will present 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

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...

Safety Governance and Risk Management Activities

• Drives pharmacovigilance and risk management planning in the clinical matrix and leads production of global Risk Management Plans for designated products
• Leads safety input into regulatory benefit-risk assessments, prepares the Risk Management Plans for designated products for submission to regulatory authorities
• Delivers the clinical safety input into clinical development planning activities
• Represents Pharma Safety 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 various documents including investigator brochures, protocols, informed consents, final study reports and external data monitoring committee charters. May lead or participate in discussion at Global Safety Board safety related findings in clinical development. Presents safety information at internal and external meetings.
• 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 SERM Head. Accountable for ensuring 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

• Drives signal detection for assigned products using available methodologies. Makes recommendations to SERM Head for the assessment and prioritisation of safety signals
• Proactively leads the assessment of safety data and discusses the results with the safety lead/product physician. Effectively communicates with key stakeholders on signal evaluation and labelling recommendations
• Leads presentations on labelling recommendations at Global Labelling Committee and 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
• 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
• 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 according to the agreed process and timelines
• Supports the Local Operating Companies by preparing license renewal documentation as required for each market
• Leads the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts

Other SERM Activities

• Drives the review or production of the SERM component of Safety Data Exchange Agreements and escalates any deficiencies to the SERM Head 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 GCSP. Contributes to advancement of methodology and process by generating new ideas and proposals for implementation
• Raises concerns/ issues 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 scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's Degree, preferably advanced degree in healthcare discipline (eg pharmacy)
• Minimum 5 years pharmacovigilance experience
• Experience in evaluation of safety signals and risk management strategies including management of labelling changes, physician and patient education
• Knowledge of statistics, epidemiology relevant to assessing drug utilization and safety at the population level
• Knowledge of medical and drug terminology and pharmacology
• Knowledge of clinical development processes
• Knowledge of global drug approval process

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Advanced Degree (PharmD, PhD)
• Minimum 5 years pharmacovigilance experience in safety evaluation role
• Expert evaluation skills and analytical thinking
• Sound knowledge of the therapeutic area of assigned GSK products
• Excellent leadership skills in the matrix team setting
• 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 external to GSK
• Highly developed negotiating and influencing skills
• Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality
• 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

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at . Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

As a health and science-based organization, GSK is committed to following the recommendations as set out by Health Canada and taking all necessary steps to help curb the spread of COVID-19 which includes getting the COVID-19 vaccine. We feel strongly that this is the best way to help protect those we value most: our employees, families, communities and the patients and consumers we serve. To that end, we are taking an important step to ensure the safety of our employees during this global public health crisis.

Only employees who are fully vaccinated against COVID-19 may attend our Mississauga and Laval corporate offices. In addition, all customer-facing employees who, as part of their job, attend healthcare settings such as hospitals, pharmacies, doctors' offices and dentists' offices will need to be fully vaccinated against COVID-19. Notwithstanding the foregoing, employees may seek an accommodation for human rights-related reasons, including medical or disability-related conditions, or religious beliefs.

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