Director, Vaccine Pharmacovigilance Benefit-Risk Physician
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
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Procurement Lead, Northern Europe
“Takeda is a unique place to work as there is no ‘every-day routine’ around here – it’s very a dynamic environment where change of plans and adjustments of approach are the constants... This allows for interesting cross-function collaboration and – if you’re up for it - a high degree of influence on your daily job and workplace.”
Regional Head, Europe, Vaccines
“Takeda is a great place to work as the company invests in the continuous development of its employees offering training, coaching, mentoring and open exchanges between all levels of the organization. Also, it is fulfilling to know that, within the Vaccine Business Unit, we are developing and delivering innovative vaccines impacting the lives of millions of people around the world.”
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
Director, Vaccine Pharmacovigilance Benefit-Risk PhysicianApply Now
DIRECTOR, VACCINE PHARMACOVIGILANCE BENEFIT-RISK PHYSICIAN
Responsible for providing support to Takeda’s Vaccine Pharmacovigilance in the monitoring of the safety profile of assigned products within agreed time frames and to a high standard of accuracy, in compliance with Takeda’s business rules, standard operating procedures and global and local regulatory requirements.
- Support developmental programs, including both early and late stage development as required.
- Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s).
- Supporting Global Head Vaccines PV, Functional management of contractors and/or junior staff supporting the assigned product
- Perform activities required to serve as Vaccine Safety Lead as outlined Takeda quality management system documents (e.g. applicable Procedures, Job Aids). This includes:
- Review and oversight of safety data and safety signal management,
- Review and/or sign off of protocols, SAPs, clinical study reports, and other documents developed for submission to regulatory authorities
- Preparation, review and and sign off of Aggregate Reports: Co-authors Aggregate Reports (PSURs, DSURs) and Ad Hoc Safety Reports (e.g., Health Hazard Evaluations).
- Interactions with external experts and regulatory agencies and partner/co-development companies
- Review of safety data and participate in dose escalation/continuation of vaccination decisions
- Authorship / sign off of Safety Monitoring Plan
- Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
- Direct the set-up of safety procedures and development of safety exchange agreements for co-development projects
- Perform activities required to serve as VBU PV representative as outlined in applicable Takeda quality management system documents (e.g. Procedures, Job Aids). This includes:
- Reviews and performs clinical evaluation of individual case safety reports of SAEs and non-serious AEs occurring in association with assigned products, including input for medical coding of events according to standard MedDRA terminology, as well as data cleaning.
- Reviews clinical protocols and other clinical development documents to ensure adequacy of safety sections, assists in the preparation of other safety documents, as required (e.g., the Investigator's Brochure (IB), CCSI).
- Responsible for the development and maintenance of the Reference Safety Information for assigned products (e.g., Company Core Safety Information DCSI / CCSI, the respective information of the Core Data Sheet and Investigator's Brochure).
- Supports the preparation of Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategies (REMS)
- Ensures integration or Benefit Risk Management framework / tools / expertise in global development and commercialization process
- Performs signal detection analyses and evaluation of potential signals, incl. respective literature search.
- Prepares, with support from cross functions, ad hoc responses to regulatory authorities in response to specific queries from regulators.
- Provides input into responses to inquiries from internal sources, health care professionals, and other external sources.
- Provides support as required for licensing activities, regulatory authority inspections, company audits, and for project product recall activities.
- Performs pharmacovigilance training and mentoring of internal and cross-functional team members.
- Participates as a safety expert in Clinical Trial Teams, Clinical Development Teams, DMC meetings, Investigator meetings, as applicable.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Minimum of 7 years experience in pharmacovigilance, clinical research or clinical development, including a minimum of 4 years in a global pharmacovigilance organisation. Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data is required and ideally experience in filing vaccines products.
- Vaccines and/or biotechnology industry experience preferred
- 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.
- Excellent understanding of pharmacovigilance-related information systems.
- Expert in Aggregate Report preparation and review.
Job ID R0010979