Job Description
The Global Product Safety Science Lead (GPSSL) is responsible to strategically lead the Safety Science activities for assigned Sobi products.
The GPSSL leads the safety science engagement throughout the product lifecycle including the development and maintenance of the clinical safety profile of the product, the ongoing safety surveillance and management, and the effective and timely communication of clinical safety to internal and external stakeholders.
The GPSSL works collaboratively with the Global Product Safety Scientist (GPSS) and other members of the Sobi Global Pharmacovigilance team, together with other functions across Sobi, to ensure that safety science activities are delivered to ethical and safety quality standards to ensure safety of patients, and compliance with GVP, GCP and worldwide regulatory requirements.
Key Responsibilities / Scope of the Job
* Lead the product level multidisciplinary Benefit Risk Team (BRT) to drive signal detection, analysis and validation, risk management and minimization strategies, risk communication, and safety labelling
Initiate BRTs for products in development (if applicable starting before the first-in-human study) and for post approval products
* Act as a Chairperson of the BRT and therefore be accountable for the BRT benefit-risk evaluation and represent the BRT at Benefit Risk Council Meetings. Ensure the operation of the BRT per SOP
* Together with the BRT, set the strategy for safety signal detection methodology, signal tracking and oversight of safety signals
* Ensure the quality of signal assessments prepared by BRT
* Accountable for benefit-risk evaluation and ensuring appropriate risk minimisation and effectiveness measures are in operation, as described in the Risk Management Plan (RMP)
* Represent Safety Science at the product level Medical Development Team. Bring pharmacovigilance and clinical safety expertise and experience as a key subject matter expert and strategic contributor
* Lead the Safety Science contribution for clinical development including providing clinical safety input to design, conduct, data analysis and interpretation. May directly fill the role of study level Safety Lead, or may work with a safety scientist as they fill the study level Safety Lead role for assigned studies. The study level Safety Lead works in close collaboration with PV Operations to ensure appropriate clinical study case processing is delivered
* The study level Safety Lead responsibilities include the preparation of Safety Management Plan in collaboration with the Partnership & Operations Manager, interpretation of safety data, participating in scientific discussions related to safety, development of documents (e.g. protocols and end-of-study reports)
* Lead the clinical safety science interactions with partner companies for the product (if applicable) including ensuring sharing of safety information per the SDEA and the collaborative functioning of the JSMT
* Proactive and effective communication with product level stakeholders related to clinical safety including MDL, CAT lead, GRA lead, and GPV Management including Safety Science management, QPPV and Head GPV
* Work effectively with the product assigned GPSS to complete safety deliverables across assigned projects. This means working collaboratively and flexibly to complete activities and to ensure continuity of safety science support
* Lead the development and implementation of signal management activities
* Provide medical and pharmacovigilance expertise e.g. for the clinical safety strategy of the product clinical development program, the development of the Target Product Profile (TPP), setting the clinical study safety standards, the development and maintenance of the RSI, including IB and CDS
* For assigned products, contribute to the analysis planning and medical thinking, and support the preparation (as required), and approval of product safety information in documents such as regulatory-required reports, medical information responses, response documents, publications, and information for external meetings
* Provide the strategic / medical direction for periodic reports including review and approval including being a key contributing author for documents describing the benefit risk of assigned products
* Review safety-related scientific literature and provide strategic input to world-wide literature strategy
* Lead the Safety Science input to the strategy of post MA activities including PASS-studies and aRMMs. Oversee the progress and delivery of these activities, including informing the QPPV of progress
* Provide safety expertise to CTD submission, regulatory interactions and defense, and geo-expansion beyond initial License Applications (NDA / BLA) and MAAs
* Provide safety scientific input to ISS Evaluation Committee as required
* In case of product quality escalations, work cross functionally to understand impacts on patients, and (if required) lead the preparation of a medical impact Health Hazard Assessment statement
* Lead the response to medical safety related enquiries from relevant sources
* Support audits and inspections as required
* Represent GPV in interactions with internal and external business partners, Regulatory Authorities, Advisory Boards, HCPs, and Key Opinion Leaders
Qualifications
Education / Learning Experience / Work Experience
Required
* Higher level biomedical or scientific qualification (e.g.. MD, PharmD or PhD)
* Ability to bring together medical knowledge and compliance with industry standards to safeguard patients, and support the delivery business goals
* Experienced Safety Science professional :
* A total of 8 years of relevant clinical practice, clinical research experience and / or employment at a Drug Regulatory Agency and / or R&D in the Pharmaceutical Industry
* At least 5 years involvement in assessment of signal evaluation and benefit / risk of medicines in a global pharmaceutical company or a Drug Regulatory Agency
* Experience working with development programs and with products with market approvals
* Experience leading cross functional global product safety management teams, successfully delivering medical safety strategy, with experience across single medical case review, the safety signal process, aggregate report writing, safety risk communication and safety risk management
* In-depth knowledge and experience of pharmacovigilance processes, practices, and regulations e.g., GCP and GVP. Knowledge of the Pharmaceutical Industry, especially clinical research, and global regulatory requirements
Desired
* Experience working with partner companies to successfully develop and market products across global markets
* Experience presenting medical safety information at Health Authority meetings
* Demonstrated expertise in the understanding, interpretation, and application of various country / regional pharmacovigilance requirements
Skills / Knowledge / Languages
Required
* High quality written and spoken English
* Effective communicator at all levels of the business
* Ability to work effectively to fulfill ambitious goals
* Sound and balanced judgment skills; able to assess and handle risks; self-confident, proactive and decisive
* Strong team-leadership capabilities. Demonstrated relationship builder both internally and externally; a strong collaborator within PV function, leadership and the wider organisation
* Has the expertise, determination and courage to resolve or elevate issues as appropriate
Desired
* Leading associates within a matrix safety team
Personal Attributes
Required
* Ability to balance medical knowledge with industry standards to achieve business goals.
* Work collaboratively in cross-functional settings and as part of matrix teams
* Strategic thinker and planner, working across a team to ensure delivery
* Proven delivery focus and solution builder
* Effective team player
Additional Information
* A purpose-driven role in a company dedicated to rare diseases.
* Mix of strategic business partnering and hands-on financial management.
* Collaborative, international environment, with opportunities for growth.
* Competitive compensation and benefit package.
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