People First
At Takeda, we are dedicated to improving the health and well-being of all individuals, bringing them the hope of a brighter future. Our passion transforms every job into meaningful action, as our people are the heart of Takeda.
Job Opportunity: Vaccines, Director PV Benefit-Risk and Signal Management Physician
We are seeking a Director PV Benefit-Risk and Signal Management Physician for a permanent, full-time position at our Zurich office in Switzerland.
Role Overview
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 accuracy and compliance with regulatory requirements, while overseeing signal detection management and medical activities related to the Benefit-Risk profile.
Your Responsibilities Include:
- 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 and Ad Hoc Safety Reports.
- Contribute to integrated summaries of safety, clinical overviews, and other registration documents.
- 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 setup and maintenance of safety signal management procedures.
- VBU PV Representative:
- Review and perform clinical evaluations of Individual Case Safety Reports.
- Ensure the adequacy of safety sections in clinical protocols and other documents.
- Review Reference Safety Information for assigned products.
- Support the integration of Benefit-Risk Management frameworks in global development.
- Prepare ad hoc responses to regulatory authorities with cross-functional support.
- Provide input to internal inquiries and assist with licensing activities.
- Conduct pharmacovigilance training and mentoring for internal team members.
- Participate as a safety expert in clinical trial teams and related meetings.
Candidate Profile:
- MD or internationally recognized equivalent.
- Minimum of 12 years in pharmacovigilance, with at least 9 years in vaccine pharmacovigilance.
- Experience in preparing responses to regulatory agencies on safety topics.
- Strong investigational event and aggregate assessment skills.
- Extensive knowledge of US/EU/APAC regulations and ICH guidelines.
- Experience communicating with FDA, EMA, and global health authorities.
- Knowledge of MedDRA coding and pharmacovigilance-related systems.
- Strong collaborative relationships in Clinical Development and Regulatory Affairs.
- High integrity and ability to manage high-stress situations effectively.
- Excellent English communication skills; proficiency in additional languages is desirable.
- Demonstrated leadership and managerial experience.
What You Can Look Forward to With Us:
- An appreciative working atmosphere in an international and dynamic environment.
- Independent work with the opportunity to shape an innovative company.
- Personal and professional development opportunities.
Empowering Our People to Shine
At Takeda, we earn the trust of society and our customers through our values of Integrity, Fairness, Honesty, and Perseverance. These values guide our actions and help us make proud decisions today and in the future. We are committed to enabling our employees to reach their full potential within an inclusive and collaborative work environment.
Diversity, Equity, and Inclusion
We are dedicated to fostering diversity, equity, and inclusion. Hiring decisions are based entirely on qualifications, regardless of gender, ethnicity, religion, sexual orientation, age, or disability.
If you are interested in this opportunity, we look forward to receiving your application. Apply online using the form below. Please note that only applications matching the job profile will be considered.