Job Description

Site Name: USA - Pennsylvania - Philadelphia
Posted Date: Apr 18 2023
Are you energized by a highly visible pharmacovigilance role that optimizes safety and risk management standards on a global scale? If so, this could be an ideal opportunity to explore. You will be 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. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following\xe2\x80\xa6
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 benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.

Why you?

Basic Qualifications:

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

• Bachelor\xe2\x80\x99s Degree in Life Sciences or Health Care related specialty with 15+ years of experience in safety and pharmacovigilance OR Master\xe2\x80\x99s Degree with 10+ years of experience.
• Leadership experience in matrix team setting including training, coaching and mentoring employees.
• Experience in medical writing & computing.
• Experience with pharmacovigilance regulations and methodologies applicable to SERM activities
• Experience in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education
• Project Management, Negotiation, & Presentation experience

Preferred Qualifications:

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

• PhD, Pharm D or other advanced Degree in Biomedical or Health Care.
• Prior experience contributing to NDAs, BLAs, sNDA, and/or MAAs
• Expert evaluation skills and analytical thinking.
• Knowledge of oncology therapeutic area.
• 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.
• Ability to manage and co-ordinate tasks, projects and processes across organization in complex and critical situations.
• Highly effective communication skills; able to present complex data to groups at all levels of the organization and externally to GSK.
• Highly developed negotiating and influencing skills Demonstrated ability to prioritize multiple tasks and deliver to deadline with high standard of quality
• Contributes innovative ideas to address new issues or improve approaches to existing operations with demonstrated ability to take a lead in driving needed change.
• Ability to adjust behaviors 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 and pharmacovigilance environment outside GSK with confidence, impact, integrity and professionalism.
• Knowledge of statistics, and epidemiology relevant to assessing drug utilization and safety at the population level.
• Knowledge of medical and drug terminology and pharmacology.
• Knowledge of clinical development process with drug approval process globally.

Why GSK?

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:

• Agile and distributed decision-making \xe2\x80\x93 using evidence and applying judgement to balance pace, rigour and risk
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

#LI-GSK GSK offers a competitive compensation package inclusive of the following: Competitive base salary, annual bonus based on company performance, access to healthcare and wellbeing programs, retirement savings program, paid time off, and employee recognition programs which reward exceptional achievements. The salary range for this role is: $255,723 to $345,978 GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s 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\xe2\x80\x99re 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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\xe2\x80\x99s compliance to all federal and state US Transparency requirements. For more information, please visit GSK\xe2\x80\x99s Transparency Reporting For the Record site.