Medical Safety Officer
Kelly Scientific is looking for a Medical Safety Officer
PURPOSE OF THE JOB:
- Manages and oversees medical safety for all assigned assessment studies within the assessment program spanning across multiple functions and pillars of the assessment program (e.g.,. clinical studies, perception and behavioral studies) pre- and post-market launch. Actively support medical safety surveillance activities occurring pre- and post-market. Serves as a technical leader and provides medical safety expertise in Medical Safety.
- Responsibilities include to establish the requirements, processes and plans related to safety monitoring and signal detection as well as the assessment, processing, communication and appropriate documentation of individual safety cases and aggregated analysis. Seamless integration with multiple sub-functions in R&D (Product Testing, Product Development) and relevant functions (Market Research, Brand Building, Operations, Law and Corporate Affairs) to support the development of the Assessment framework, strategy and plan from a medical safety point of view.
- Medical Safety Officer assigned clinical studies accountable for planning, implementation and execution of all state of the art safety monitoring activities in compliance with operating processes and all applicable ICH, regulatory and legal requirements as well as scientific standards.
- Establishes and implements medical safety related policies, procedures and programs related to assigned assessment studies in humans and has a leadership role in collaboration with strategic partners for medical safety.
- Accountable for the management, assessment, processing and communication of all Serious Adverse Events and events of interest subjects to expedited reporting occurring in assessment studies, including the preparation of case reporting to the respective authorities and Institutional Review Boards/Ethic Committees within the timelines set by local authorities.
- Develop all state of the art safety related documentation (i.e. Safety Management Plans), ensure safety training of relevant partners and functions and take on accountability for all medical safety related sections in key documents for clinical assessment (such as study protocol, investigator's brochure, clinical study reports, publications, presentations, post-hoc analyses) for all assessment studies.
- Guide the clinical study teams, external partners and internal stakeholders with regards to questions related medical safety in assessment studies in a clear, concise and timely manner.
- Actively contribute to the clinical assessment team duties, such as maintenance and improvement of processes, GCP trainings, managerial reporting, and team presentations.
- Establish and maintain close relationship with Regulatory and Scientific affairs to ensure close collaboration and efficient processing and reporting of safety cases to regulatory authorities
- Actively contribute to the business continuity of the medical safety duties by acting as medical back-up to other medical safety officers engaged in assessment studies or in postmarket safety surveillance activities
- Highly cross-functional environment with broad scientific and technical complexity requires a multi-layer scientific experience together with exceptional ability of driving for results and interpersonal/corporate savviness used for cross-functional integration and building effective functional matrix teams at the same time. Lead complex activities, work under high pressures to complete activities and co-ordinate activities with stakeholders and peers.
- A highly uncertain regulatory environment while aiming at shaping requires embracing change and constant agility.
- Leverage and transition of safety processes acquired from well-established pharmaceutical/medicinal framework into the emerging framework products require a significant level of agility and open mindset.
- Independent judgment, comfort around standing alone is required to perform all necessary activities related to medical safety and to provide technical guidance.
- Alignment with internal and external stakeholders (incl. heads of function, external expert panels) from multiple different global functions and defining and executing medical safety monitoring/safety surveillance to support a risk modification in focus and herewith protecting the company’s future revenues.
SKILLS AND COMPETENCIES
- Physician with medical doctor diploma (MD board certification).
- A degree in a medical/pharmacology specialty an asset (such as pharmaceutical medicine, clinical pharmacology, internal medicine, cardiology, physiology, respiratory diseases, pharmacovigilance)
- 5-yr experience in medical safety acquired in industry, CRO or academia. Experience in medical monitoring activities an additional asset. The experience should mainly be focused on methods, processes, assessment and reporting used in the area of the scientific/clinical/medical aspects in clinical studies.
- Additional expertise gained through education, experience and training in at least one of the following domains: pharmaceutical medicine, pharmacovigilance, clinical pharmacology, pharmacokinetics.
- Sounds knowledge with regards to safety signal detection would be an asset.
- Good knowledge of ICH CGP (track record of GCP trainings), GEP and pharmacovigilance related guidelines and rules in US, EU and JP.Basic knowledge in data analysis.
Your contact at Kelly Scientific:
PhD in Biology and Health
Consultant Professional Staffing Life Science and Deputy Manager