SERM Principal Scientist

GSK; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Flexible working

Job summary

GSK is seeking a Pharmacovigilance professional to lead signal detection, safety evaluation, and risk management across clinical development and post-marketing settings. You will prepare evaluation documents for regulatory requests and support RMPs, with exposure to global safety governance and inspection readiness.

Applicants should have a health sciences or pharmacy-related degree and proven pharmacovigilance experience.

Qualifications

• Bachelor-level degree in health sciences, pharmacy, nursing or related field.
• Experience in pharmacovigilance, safety evaluation and risk management across clinical development and post-marketing.

Responsibilities

• Lead signal detection and evaluation activities for assigned products.
• Ensure safety data evaluations and risk assessments support regulatory requests.
• Contribute to RMPs and regulatory periodic reports with timely, high-quality outputs.
• Support inspection readiness and post-audit activities within required timelines.
• Collaborate with cross-functional teams to address safety issues and governance needs.

Skills

PV Expertise

Safety Evaluation

Signal Detection

Cross-functional Collaboration

Regulatory Knowledge

Education

Health sciences/Pharmacy/Nursing degree

Tools

Regulatory reporting tools

Job description

Provides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting. Ensures 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 (Healthcare Professionals). Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally., Scientific/Medical Knowledge PV Expertise

• Responsible for signal detection and evaluation activities for assigned products. Input into review and assessment of clinical and post-marketing safety data to identify and manage potential risks.
• Ensures that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data.
• Assists in the production of Risk Management Plans (RMPs)/Risk Tables for designated products, in consultation with senior personnel.
• Contributes to authoring of regulatory periodic reports and associated documentation globally according to the agreed process and timelines - reviews and contributes to production of program documents such as protocols and aggregate safety reports.
• Supports inspection readiness and completes any post audit/inspection activities within the required timeline.
• Uses a range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues/problems, and makes decisions with consultation of Safety Lead/Group Lead.
• Shows commitment to the task and effective time management to meet multiple deadlines successfully and with attention to detail and quality. Able to prioritise own workload with minimal guidance.

Cross Functional Matrix team leadership

• Builds effective working relationships and responds to the needs of line functions in the matrix in relation to safety issues.
• Supports safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM (Safety Evaluation and Risk Management) to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.

• Can explain knowledge and skills, and work in new situations. Degree in Health Sciences, Pharmacy, Nursing or a related healthcare discipline, such as Bachelor of Science (BSc), Master of Science (MSc), Doctor of Philosophy (PhD), Registered Nurse (RN), Bachelor of Science in Nursing (BSN), Master of Science in Nursing (MSN), Nurse Practitioner (NP), Registered Pharmacist (RPh), Bachelor of Pharmacy (BPharm), or Doctor of Pharmacy (PharmD).
• Experience in pharmacovigilance, safety evaluation and risk management, covering clinical development and post-marketing activities.

Preferred Qualification

• Familiarity with international pharmacovigilance requirements and guidance, including International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Pharmacovigilance Practices (GVP), and Council for International Organizations of Medical Sciences (CIOMS) guidance.
• Experience with drug development and regulatory approval processes.
• Experience working in a large, matrix organisation., Digital Fluency, Enterprise Leadership, Influencing Without Authority, Pharmacovigilance, Presentation Techniques Uniting science, technology and talent to get ahead of disease together.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide.