Join Takeda: Vaccines, Director PV Benefit-Risk and Signal Management Physician
At Takeda, we prioritize the health and well-being of all individuals, bringing forth the hope of a brighter future. Our passion transforms every role into meaningful action, making our people the heart of the company.
We are currently seeking a Director PV Benefit-Risk and Signal Management Physician for our Zurich office. This is a permanent, full-time position.
Key Responsibilities:
As the Director PV Benefit-Risk and Signal Management Physician, you will provide essential medical support by monitoring the safety profile of our assigned vaccine products. Your role will ensure high accuracy and compliance with regulatory requirements while overseeing signal detection management and medical activities relevant to the Benefit-Risk profile.
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.
- Write Safety Signal Assessment reports and Ad Hoc Safety Reports (e.g., Health Hazard Evaluations).
- Contribute to integrated summaries of safety and registration documents for new and supplemental NDAs.
- 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 signal management procedures.
VBU PV Representative:
- Review and perform clinical evaluations of individual case safety reports, including medical coding and data cleaning.
- Ensure the adequacy of safety sections in clinical protocols and related clinical development documents.
- Review Reference Safety Information for assigned products.
- Support the integration of Benefit-Risk Management frameworks in global development processes.
- Prepare ad hoc responses to regulatory authorities with cross-functional support.
- Provide input into inquiries from internal stakeholders and external healthcare professionals.
- Assist with licensing activities, regulatory inspections, audits, and product recall activities.
- Conduct pharmacovigilance training for team members.
- Participate as a safety expert in Clinical Trial Teams and related meetings.
Your Profile:
- MD or an internationally recognized equivalent.
- At least 12 years of experience in pharmacovigilance, clinical research, or development, including 9 years in vaccine pharmacovigilance.
- Experience in preparing regulatory responses on safety-related topics and filing vaccine products.
- Strong skills in investigational event assessment and documentation.
- Extensive knowledge of US/EU/APAC regulations and ICH guidelines.
- Proven experience in communicating with the FDA, EMA, and other health authorities.
- Familiarity with MedDRA coding and pharmacovigilance-related systems.
- Strong internal collaboration abilities across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, and Legal Counsel.
- High integrity, sense of urgency and a collaborative spirit.
- Excellent English communication skills; proficiency in additional languages is a plus.
- Able to manage high-stress situations calmly and effectively.
- Demonstrated success in building effective team structures and managing external resources.
- Leadership or managerial experience.
Why Join Us:
- An appreciative working atmosphere within an international, dynamic environment.
- Independence to contribute to an innovative company.
- Opportunities for professional and personal development.
Empowerment Through Values:
At Takeda, we earn the trust of society and our customers through our values: Integrity, Fairness, Honesty, and Perseverance. These principles guide us in our decision-making and drive our commitment to employee development. As a global top employer, we offer exciting career paths, foster innovation, and strive for excellence in all we do.
Diversity, Equity, and Inclusion:
Takeda is dedicated to promoting diversity, equity, and inclusion. Our hiring decisions are based solely on qualifications, free from bias regarding 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.