SERM Director, Safety Scientist

Responsible to lead medical and scientific staff within the SERM (Safety Evaluation & Risk Management) and defining and driving the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies.

As a senior member of the Global Safety organization the role is responsible to:

• Implement policy processes and support the implementation of operational and strategic plans
• Ensure scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization management and communication of safety risks
• Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs.Supporting the pharmacovigilance and benefitrisk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.

Scientific/Medical Knowledge PV Expertise

• Expert in clinical safety and pharmacovigilance activities.

• Demonstrated record of sound judgement and decision making in safety evidence generation benefitrisk assessment 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 in the real world.

• Coaches and mentors SERM colleagues in the scientific/medical aspects of signal evaluation methodology and risk management and preparation of regulatory safety reports and other documents.

• Demonstrated track record of quality decision making and creative problem resolution in critical situations based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.

• Provides excellent medical/scientific judgment strong analytical skills proactive approach in drug safety and high sense of urgency.

• Champions/sponsors safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings. Anticipates detects and addresses product safety issues and ensures that riskreduction strategies are implemented appropriately.

• Leads crossGSK activities such as safety advisory panels interfaces with and assumes ad hoc membership of a Senior Governance Committee.

• Ability to engage in and contribute to broad GSK environment and pharmacovigilance environment outside GSK with confidence impact integrity and professionalism.

Crossfunctional Matrix team leadership

• Champions/sponsors safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings. Anticipates detects and addresses product safety issues (e.g. product incidents) and ensures that riskreduction strategies are implemented appropriately.

• Proven ability to affect department or product strategies with a strong understanding and ability to incorporate global considerations into decision making.

• Builds strong collaborative relationships and displays excellent leadership skills on safety issues whilst working in a matrix team with an outstanding track record leading a team in a matrix setting.

• Demonstrates resilience and ability to adjust behaviours and priorities based on changing environment.

• Leads or oversees SERM contribution to due diligence activities.

Communications (verbal written) and Influencing (internal PV Governance and External LTs)

• Excellent communication (verbal written) and influencing (internally and externally) skills.

• Leads crossGSK activities such as safety advisory panels interfaces and assumes ad hoc membership of a Senior Governance Committee. Influences others external to GSK to meet organisational objectives and may be recognised as a key player in external international pharmacovigilance activities (i.e. may be a member of trade association or external initiatives).

• Leads driving change until their implementation.

• Recognised as an authority with expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.

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

• Health Sciences/Health Care Professional degree required (e.g. BSc MS PhD RN/BSN/MSN NP RPh/B Pharm/Pharm D Dentists and Veterinarians are also accepted).

• Comprehensive experience in the Pharmaceutical or Biotech industry working in Drug Safety or Pharmacovigilance

• Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management encompassing both clinical development and postmarketing activities

• Knowledge/experience of international pharmacovigilance requirements (e.g. ICH GVP modules CIOMS initiatives) and drug development and approval processes.

Preferred Qualifications:

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

• Advanced Degree
• Experience working in large matrix organisations
• Experience in Oncology

Why GSK

Uniting science technology and talent to get ahead of disease together.

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. We prevent and treat disease with vaccines specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas (infectious diseases HIV respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome valued and included. Where they can keep growing and look after their wellbeing. So if you share our ambition join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you we encourage you to explore with our hiring team what the opportunities are.

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