Descripción
People First - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. Our people are the heart of Takeda.
For Takeda Switzerland we are looking for a
Vaccines, Director PV Benefit-Risk and Signal Management Physician
in a permanent position/ full time at our Zurich office.
As the Director PV Benefit-Risk and Signal Management Physician, you will provide medical support in monitoring the safety profile of assigned vaccine products, ensuring high accuracy and compliance with regulatory requirements, and oversee signal detection management and medical activities relevant to the Benefit-Risk profile.
Your tasks in detail:
Signal Management Lead:
Evaluate and manage potential signals, including literature searches.
Supervise signal detection activities conducted by vendors.
Assess Individual Case Safety Reports and aggregate safety data.
Write Safety Signal Assessment reports, Ad Hoc Safety Reports (e.g., Health Hazard Evaluations), and safety assessments for regulatory submissions.
Contribute to integrated summaries of safety, clinical overviews, and other registration documents for new and supplemental NDAs and/or ex-US new drug submissions.
Lead data analysis and coordinate responses to safety signal-related questions from regulators.
Manage interactions with external experts, regulatory agencies, and partner/co-development companies.
Direct the set-up and maintenance of safety signal management procedures.
VBU PV Representative:
Review and perform clinical evaluations of individual case safety reports of SAEs and non-serious AEs, including medical coding and data cleaning.
Ensure the adequacy of safety sections in clinical protocols and other clinical development documents; assist in preparing other safety documents (e.g., Investigator's Brochure, CCSI).
Review Reference Safety Information for assigned products (e.g., Company Core Safety Information DCSI/CCSI, Core Data Sheet, Investigator's Brochure).
Support the integration of Benefit-Risk Management frameworks, tools, and expertise in global development and commercialization processes.
Prepare ad hoc responses to regulatory authorities with cross-functional support.
Provide input into responses to inquiries from internal sources, healthcare professionals, and other external sources.
Assist with licensing activities, regulatory authority inspections, company audits, and project product recall activities.
Conduct pharmacovigilance training and mentoring for internal and cross-functional team members.
Participate as a safety expert in Clinical Trial Teams, Clinical Development Teams, DMC meetings, and Investigator meetings.
Your profile:
MD or internationally recognized equivalent.
Minimum of 12 years in pharmacovigilance, clinical research, or clinical development, including at least 9 years in vaccine pharmacovigilance within a global organization.
Experience in preparing responses to regulatory agencies on safety-related topics, aggregate analysis of safety data, signal management, and filing vaccine products.
Strong investigational event and aggregate assessment/review/documentation skills.
Extensive working knowledge of US/EU/APAC regulations and ICH guidelines.
Proven experience in communicating with the FDA, EMA, and other global health authorities.
Sound working knowledge of MedDRA coding and pharmacovigilance-related information systems.
Proven collaborative internal relations with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, and Legal Counsel.
High integrity, sense of urgency, ability to recognize time sensitivity, willingness to be a "player/coach."
Excellent English written and verbal communication skills; additional languages (e.g., Spanish, Japanese, German) desired.
Ability to deal calmly and effectively with high-stress situations, persevering and remaining calm in challenging circumstances.
Demonstrated success in building effective matrix working teams, systems, and processes; ability to identify, select, and manage a variety of external resources.
Leadership/managerial experience.
What you can look forward to with us:
Appreciative working atmosphere in an international and exciting working environment with a wide range of development opportunities
Independent work with the opportunity to play a part in shaping an innovative company
Professional and personal development opportunities
Empowering our people to shine
At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world. Learn more at takedajobs.com.
Diversity, Equity and Inclusion
Takeda is committed to foster diversity, equity and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age or disability.
If you are interested in this opportunity, we look forward to receiving your application via our online tool!