Join Our Team at Takeda
At Takeda, we are dedicated to improving the health and well-being of all individuals, inspiring hope for a brighter future. Our passion drives us to transform every role into meaningful action, making our people the heart of Takeda.
Position: Vaccines, Director PV Benefit-Risk and Signal Management Physician
We are seeking a talented professional for a permanent, full-time position at our Zurich office.
Role Overview
As the Director of PV Benefit-Risk and Signal Management Physician, you will provide crucial medical support in monitoring the safety profiles of assigned vaccine products. Your expertise will ensure high accuracy and compliance with regulatory requirements, overseeing signal detection management and medical activities relevant to the Benefit-Risk profile.
Your Responsibilities
- 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 (e.g., Health Hazard Evaluations).
- 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 setup 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.
- Ensure the adequacy of safety sections in clinical protocols and other clinical development documents.
- Review Reference Safety Information for assigned products.
- Support the integration of Benefit-Risk Management frameworks, tools, and expertise in global processes.
- Prepare ad hoc responses to regulatory authorities with cross-functional support.
- Assist with licensing activities, regulatory authority inspections, and company audits.
- Conduct pharmacovigilance training and mentoring for team members.
- Participate as a safety expert in Clinical Trial Teams and other relevant meetings.
Your Profile
- MD or internationally recognized equivalent.
- Minimum of 12 years in pharmacovigilance, clinical research, or clinical development, with at least 9 years in vaccine pharmacovigilance.
- Experience preparing responses to regulatory agencies on safety-related topics.
- Strong investigational event assessment and documentation skills.
- Extensive knowledge of global regulations and ICH guidelines.
- Proven experience in communication with regulatory authorities.
- Solid understanding of MedDRA coding and pharmacovigilance information systems.
- Highly collaborative with cross-functional teams.
- Excellent written and verbal communication skills in English; additional languages are a plus.
- Able to thrive in high-stress situations while maintaining composure.
- Demonstrated success in building effective teams and processes.
- Leadership and managerial experience.
What We Offer
- An appreciative working atmosphere in an international and stimulating environment.
- Opportunities for independent work and participation 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 core values: Integrity, Fairness, Honesty, and Perseverance. These values guide our actions and help us make proud decisions that shape a better future. As a global top employer, we offer exciting career paths and promote innovation within an inclusive and collaborative work environment.
Diversity, Equity, and Inclusion
Takeda is committed to fostering diversity, equity, and inclusion. Our hiring decisions are based solely on qualifications, regardless of gender, ethnicity, religion, sexual orientation, age, or disability.
If you are interested in this opportunity, apply online using the form below. Please note that only applications matching the job profile will be considered.