Vaccines SERM Head
Site Name: USA - Maryland - Rockville Posted Date: Aug 4 2021 Are you a safety/pharmacovigilance physician with in-depth and hands-on experience, looking to lead and develop a great team? Reporting to the Head of Vaccines Clinical Safety and Pharmacovigilance (VCSP), the US SERM Head is responsible for providing pharmacovigilance and risk management expertise in overseeing the benefit-risk strategy for the portfolio of vaccines allocated to the regional R&D Center (RDC). The individual will lead and mentor a team of safety physicians and scientists assigned to the portfolio and be responsible for direct management of the team. The SERM Head must demonstrate agility, ability to prioritize, and capability to function at a high level with cross-functional leaders at the RDC. This person must be experienced working in a matrix environment to advance the safety and biological understanding of compounds throughout the life cycle. The individual who assumes this position will interact with multiple levels of management within GSK and with external stakeholders and is expected to be able to influence the strategic direction of complex issues for the assigned portfolio. The role reports to the VP, Vaccines Clinical Safety & Pharmacovigilance. As US SERM Head, a typical day might include Leading and overseeing safety and risk management activities for clinical development and marketed vaccines within the RDC portfolio Managing and developing a team of direct and indirect reports of safety physicians and scientists Ensuring key safety documents and deliverables (e.g., safety-related sections of clinical protocols, ICFs and CSRs, signal assessment reports, reference safety information, aggregate reports, regulatory submissions and responses, safety content for internal and external communications) meet standards of quality and timeliness Serving as primary point of contact for all patient safety-related activities at the RDCProviding direction and strategy on process improvements, individual and team interactions and overall SERM efficiency GSK considers the clinical safety of its products to be of paramount importance. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Key Responsibilities Lead the medical and scientific staff within SERM (Safety Evaluation & Risk Management) and defining and driving the strategy and vision of VCSP in alignment with business strategies, increased efficiency and effectiveness to meet the needs of the PV systems and Vaccines pipeline Create and build an organization to train and recruit leaders to drive the practice and science of safety, participating as a leader in SERM governance Accountable for coordination of medical and scientific SERM resource to Vaccine projects, process initiatives and Due Diligence activities, providing adequate management and ensuring development of SERM staff Actively manage and evaluate risks associated with GSK Vaccines' products under the SERM, and accordingly, make recommendations for the management and communication of the identified risk. The incumbent is responsible for ensuring adverse event documentation and follow-up processes are in compliance with legal and regulatory statues for all marketed products Ensuring that the signal evaluation process for each Therapeutic Area (TA) under the position is customized and managed in order to maximize its efficiency Monitor the safety profile of licensed products based on all sources and in collaboration with other departments and translate this monitoring into appropriate safety risk management activities Liaise with Legal, Regulatory and Medical Affairs departments regarding provision of medical expertise concerning reported adverse events, adequacy of information in promotional material fair balance statements and development and conduct of Clinical Trials as it relates to the management of safety data Participate and attend all relevant meetings/educational seminars to ensure that knowledge of pertinent medical or Pharmacovigilance issues are up to date Risk Management Planning Participate in the management of Reference Safety Information reviews/revisions Accountable for the development of Benefit/ Risk assessments for products under portfolio May function as Safety Lead for one or more products, or as delegate for Head of VCSP Responsible for forecasting resource needs according to prioritization of programs within portfolio, and ensuring resources are appropriate to achieve business objectives Keeping upper management informed of key benefit-risk inflections for assigned portfolio Overseeing preparation of materials for, and supporting presentation by team, to the Vaccine Safety Monitoring Board or Global Safety Board Developing and maintaining relationships with other leaders in Global Safety and cross-functional teams Performing and overseeing business development evaluations and recommendations from the patient safety perspective. May represent VCSP or Global Safety as a technical expert at external meetings, DSMB, or regulatory authority meetings. Complexity Due to the universal application of safety at all levels of vaccine discovery, development and life cycle management and therefore its impact on overall portfolio, sales and growth of GSK Vaccines, the role works: Across the R&D, Clinical R&D, Commercial Strategy, and the Regulatory matrix environment Across product pipeline in development and products in the market Partners with other SERM Heads, Heads of Safety as well as the EU-QPPV Management of global safety teams includes the following: People management, recruiting, training, development and retention of high calibre staff Aligning regional with global objectives Compliance with internal policies, processes and external regulations Forecasting resource needs and resource allocation across groups and sites. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: - MD or MD/PhD; ( board certified or board eligible) with sub-speciality training in vaccinology, immunology or infectious diseases highly preferred. Clinical medical practice experience is highly recommended - Significant relevant pharmaceutical industry experience with a successful track record in in safety and risk management - Must have a strong understanding of FDA, EMA and other Health Agency regulations regarding post-marketing surveillance - Extensive knowledge and understanding of PV deliverables, standards and processes at a global level - Additional experience in Pharmaceutical Medicine (Drug Discovery, Drug Development, Medical Affairs, Medical Information) is an asset - Ability to navigate across a matrixed environment - People management experience - Excellent written and oral communication skills - Strong scientific acumen and the ability to work in a dynamic matrixed environment are key traits for an individual in this role Preferred Qualifications: If you have the following characteristics, it would be a plus: Sub-speciality training in vaccinology, immunology or infectious disease Clinical medical practice experience is highly recommended Additional experience in Pharmaceutical Medicine (Drug Discovery, Drug Development, Medical Affairs, Medical Information) is an asset 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 - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritisation, execution, delivering performance. Setting strategic direction and leading on-going organisational transformation. Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit. 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