SERM Principal Scientist

Job Title: SERM Principal Scientist   JobPurpose                                                                                                                         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. Key Responsibilities 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.  Basic Qualifications • 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 dev