Join Our Team at Takeda
At Takeda, we are dedicated to improving the health and well-being of individuals, bringing them the hope of a brighter future. Our passion transforms every role into meaningful actions, making our people the heart of our organization.
Position Announcement
We are currently seeking a Director PV Benefit-Risk and Signal Management Physician for our Zurich office. This is a permanent, full-time position at Takeda Switzerland.
Role Overview
As the Director PV Benefit-Risk and Signal Management Physician, you will provide critical medical support in monitoring the safety profile of assigned vaccine products, ensuring high accuracy and compliance with regulatory requirements. You will oversee signal detection management and relevant medical activities associated with the Benefit-Risk profile.
Your Responsibilities
Signal Management Lead:
- Evaluate and manage potential signals, including conducting literature searches.
- Supervise signal detection activities performed by vendors.
- Assess Individual Case Safety Reports and aggregate safety data.
- Draft 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 inquiries from regulators.
- Manage interactions with external experts, regulatory agencies, and partner/co-development companies.
- Direct the establishment and maintenance of safety signal management procedures.
VBU PV Representative:
- Review and assess clinical evaluations of individual case safety reports, including medical coding and data cleaning.
- Ensure the adequacy of safety sections in clinical protocols and other clinical development documents; assist in preparing 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 entities.
- 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 Qualifications
- MD or internationally recognized equivalent.
- A minimum of 12 years in pharmacovigilance, clinical research, or clinical development, with 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 the filing of vaccine products.
- Strong investigational event and aggregate assessment, review, and documentation skills.
- Extensive knowledge of US/EU/APAC regulations and ICH guidelines.
- Proven experience in communicating with the FDA, EMA, and other global health authorities.
- Solid knowledge of MedDRA coding and pharmacovigilance-related information systems.
- Demonstrated collaborative relationships with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, and Legal Counsel.
- High integrity, sense of urgency, and the ability to recognize time sensitivity, along with a willingness to be a "player/coach."
- Excellent English written and verbal communication skills; knowledge of additional languages (e.g., Spanish, Japanese, German) is desired.
- Ability to manage high-stress situations calmly and effectively.
- Demonstrated success in building effective matrix working teams, systems, and processes, as well as identifying, selecting, and managing various external resources.
- Leadership and managerial experience.
What We Offer
- An appreciative working atmosphere in an international and dynamic environment with diverse development opportunities.
- The ability to work independently while contributing to the shaping of an innovative organization.
- Professional and personal development opportunities.
Empowerment and Values at Takeda
We empower our people to shine. At Takeda, we earn the trust of society and our customers by living our values of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. These values guide us in all our actions, helping us make decisions of which we can be proud now and into the future. We enable our employees to realize their full potential and, as a global top employer, we provide exciting career paths, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to 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 fostering diversity, equity, and inclusion. Our hiring decisions are based entirely on qualifications, made without regard to gender, ethnic origin, religion, sexual orientation, age, or disability.
If you are interested in this opportunity, please apply online using the form below. Please note that only applications matching the job profile will be considered.