- Co-leads DSE CSPV Specialty Medicines product team to manage safety profiles of assigned assets with oversight of junior physicians or scientists
- Accountable for all aspects of safety surveillance and risk management activities for assigned product portfolio (e.g. Oversees the development, maintenance of Safety monitoring plan, execute on safety monitoring activities including signal detection reports, signal assessment reports, development of and submission of relevant RMPs, aggregate reports (PSURs/DSURs) for designated products
- Provide mentoring and management development of junior physicians and scientists for their increase in expertise and compentcies
- Engage with global and cross functional to manage safety profiles -- Chair SMT meetings, and represent CSPV in cross-functional meetings and engages with colleagues in Medical affairs, Regulatory Affairs, Quality, etc, including participating in regulatory interactions
- Provide strategic guidance in the preparation of safety relevant parts of submission documents (e.g., CSR, Summary of Safety, B/R sections of the Clinical Overview modules of submission dossier, Post Authorization Safety Studies (PASS) and non-interventional studies (NIS), CCDS, SmPC, responses to HA safety queries)
- Manages regulatory responses to emerging safety issues and provides strategies to address these, and follow-though on post approval safety commitments
- Implements risk mitigation for designated products and oversees the global communication of important product safety information
- Contribute to Center of Excellence (CoE) activities/initiatives that are across assets (including but not limited to RMP, Signal Detection and Management, and ICSR medical review)
- Works with CSPV senior management to create and align processes that address global CSPV objectives, and for resource planning.
- Contribution to maintenance of Pharmacovigilance Quality Management System including creation and maintenance of Standard Operating Procedures (SOPs) within Clinical Safety & Pharmacovigilance department
- Contribution to audits/inspections for concerned products/projects.
- University Degree in Medical Science with at least 8 years of work experience
- Experience in summarizing and presenting safety data
- Effective oral and written communication skills
- Experience in project management and able to work in a global and matrix environment
- People management experience (direct or in matrix) is preferred
- International, European and PV laws
- Fluent business English (oral and written)
- Excellent Benefits
- Work-Life Balance
- Growth and Development
- Health and Wellbeing Support
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Physician - Speciality Medicine, Risk Management (m/f/d) - Landshut, Deutschland - Daiichi Sankyo Europe GmbH
Beschreibung
Passion for Innovation. Compassion for Patients.
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
For our headquarter in Munich or other affiliates in Europewe are seeking highly qualified candidates to fill the position
Senior Director Safety Physician Specialty Medicines (m/f/x)The position:
Provides expertise in medical safety activities for the assigned projects / products including development of safety monitoring plan, effective implementation of safety monitoring activities, Benefit/Risk assessment with appropriate risk minimization activities, and effectively communicates with internal and external stakeholders, within the framework of safety management team (SMT). The incumbent provides strong leadership to successfully coordinate resources, ensures effective collaboration, and ensures delivery of all essential activities across the life cycle of the assigned products, either directly or via mentoring / management of junior physicians or scientists. Essential clinical safety activities for marketed and development products include but not limited to the following: (such as signal detection activities, chairing of SMT, signal assessment reports, review of study protocols, ICF, IB, CSR, submission activities for new indications / line extensions, response to HA requests, aggregate reports, RMPs, label changes, and deliver on post approval commitments)
This position will also contribute to the Centers of Excellence activities (e.g. Risk Management, Signal Detection, and medical review of ICSRs).
Reporting:
Reports to the European Senior Director Oncology Value, Access & Pricing
Roles and responsibilities:
