SERM Associate Scientific Director

Site Name: UKLondon New Oxford Street, Durham Blackwell Street

Posted Date: Apr

Overview

Provides medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post marketing setting.

Ensures scientifically sound review and interpretation of data and management of safety issues, escalating 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.

Responsibilities

• Be responsible for signal detection and evaluation activities for assigned products.
• Drive the production of regulatory periodic reports and associated documentation and Risk Management Plans (RMPs) globally, in line with agreed processes and timelines, advising on content in partnership with the Product Physician.
• Author the SERM safety contribution to global regulatory submissions in partnership with the Product Physician.
• Respond to auditor and inspector requests for information or additional information and complete corrective and preventative actions (CAPAs) within agreed timelines.
• Apply advanced evaluation skills and analytical thinking to literature review, data gathering, data synthesis, analysis, and interpretation.
• Make sound decisions based on relevant information gathered from a broad range of sources, seeking input as needed, and identifying, evaluating, and recommending solutions to problems.
• Demonstrate strong commitment to delivery by prioritising activities effectively, meeting multiple deadlines, and maintaining high performance standards and attention to detail.
• Support and facilitate safety governance and Safety Review Teams (SRTs) in clinical development and post marketing settings by assisting in the establishment and operation of cross functional teams to detect and address product safety issues.
• Ensure that risk reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
• Lead or participate in cross functional process initiatives and Process Workstreams to improve adherence to regulations, data standards, quality, and efficiency.
• Author or contribute to written standard updates (e.g. SOPs) to ensure policies and regulations are applied consistently and correctly.
• Build strong collaborative relationships and demonstrate effective matrix leadership, proactively providing input to teams on safety issues and processes, including coaching and mentoring others as appropriate.
• Present complex issues to senior staff members and GSK Senior Governance Committees.
• Demonstrate initiative and creativity in performing tasks and responsibilities, proactively contributing ideas to improve existing operations.
• Participate in process improvement initiatives within GCSP and contribute to the advancement of methodologies and processes through new ideas and proposals for implementation.
• Communicate effectively within matrix teams, presenting ideas and data clearly and concisely, while listening and responding appropriately to feedback.
• Produce high quality medical and scientific written outputs, including detailed evaluations and reports on major GSK products.
• Apply effective negotiation, influencing, and persuasion skills to enable understanding and alignment across matrix teams.

Basic Qualifications & Skills

• Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D).
• Substantial experience in pharmacovigilance or drug development.
• Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post marketing activities.
• Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
• Experience working in large matrix organizations.

Preferred Qualifications & Skills

• Advanced degree preferred.

Closing Date

12th of May (COB)

Equal Opportunity Employer

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.

If you require adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us at . Please note that if your enquiry does not relate to adjustments we will not be able to support you through these channels.