Job Title: Pharmacovigilance and Risk Management Expert
Location: Home Worker - USA, Durham Blackwell Street, GSK HQ, Home Worker - GBR, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Posted Date: Jan 6, 2025
GSK is a global healthcare company focused on improving human life by enabling people to do more, feel better, and live longer. We are committed to discovering, developing, and delivering innovative medicines, vaccines, and consumer healthcare products. At GSK, we strive to create a diverse and inclusive workplace that reflects the communities we serve, offering competitive compensation, benefits packages, and opportunities for professional development.
Job Purpose:
The Pharmacovigilance and Risk Management Expert provides in-depth medical and scientific expertise for the safety evaluation and risk management of key GSK assets in both clinical development and post-marketing settings. The role involves ensuring scientifically sound reviews and interpretations of data, managing safety issues, and escalating concerns to senior management when appropriate. The position also focuses on supporting pharmacovigilance and benefit-risk management of GSK’s global assets to ensure patient safety.
Key Responsibilities:
Scientific/Medical Knowledge & PV Expertise: Lead pharmacovigilance and risk management planning, ensuring the evaluation of issues across clinical settings. Lead safety components of global regulatory submissions and demonstrate expert evaluation skills in literature reviews and clinical data analysis.
Cross-functional Matrix Team Leadership: Develop and execute safety strategy in clinical development and post-marketing settings. Lead safety governance teams (SRTs) and collaborate across functions to address product safety issues and implement risk-reduction strategies. Represent GSK on cross-functional teams and contribute to process improvements.
Communication & Influence: Lead presentations on safety issues to senior leadership and regulatory authorities. Communicate with internal and external stakeholders, influencing decision-making on safety matters. Contribute to the development of long-term clinical strategies and ensure alignment with external regulations.
Process Improvement: Participate in or lead cross-functional teams to improve processes for data standards, quality, and efficiency. Support inspection readiness and audits.
Basic Qualifications:
Preferred Qualifications:
Salary and Benefits:
The annual base salary for this role ranges from $195,000 to $325,000, depending on factors such as work location, candidate skills, experience, and market rates. Additional benefits include health care, retirement benefits, paid holidays, and paid caregiver/parental leave. Eligible candidates may also participate in a share-based long-term incentive program.
Why GSK?
GSK’s mission is to unite science, technology, and talent to get ahead of disease. We work to positively impact the health of billions of people while delivering stronger, more sustainable shareholder returns. At GSK, we’re committed to creating a workplace where people can thrive, feel inspired, and grow.
GSK is an Equal Opportunity Employer. We adhere to Affirmative Action principles to ensure equal consideration for all qualified applicants, regardless of race, gender, disability, or other protected characteristics.
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