Head of Pharmacovigilance - Vaccines - Switzerland
Head of Pharmacovigilance - Vaccines
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Head of Pharmacovigilance - Vaccines, based in Zurich.
Takeda is a global pharmaceutical leader with more than 31,000 professionals working together across 70 countries. We have an unwavering dedication to put people first and we live our values of Takeda-ism—Integrity, Fairness, Honesty, and Perseverance. We are united by our 235-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
This position is responsible for the oversight of Takeda`s Vaccine Pharmacovigilance Department, including leadership of the Pharmacovigilance personnel, scientist and physicians who serve as Global Safety Leads for complex, strategically important developmental programs as well as activities to support commercialized global Vaccines.
- In conjunction with Vaccines Sr. Leadership, ensures effective functioning of the department including establishment and maintenance of compliant pharmacovigilance systems and processes and strategic and long-term planning, and resource and budget forecasting and tracking
- Leads and directs interpretation of safety data from internal and external studies and communicates at senior leadership level the impact of the data in terms of “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timeline or product labeling
- Responsible for overseeing the safety evaluation and of the assessment of benefit-risk balance for vaccines in clinical development and postmarketing setting (except for vaccines solely licensed in Japan).
- Responsible for establishing and maintaining vaccine safety governance within VBU by the: Oversight and leadership of Vaccine Safety Teams (VSTs) & Triaging of vaccine safety issues to the Takeda Safety Board (TSB), in collaboration with the VBU Global Medical Officer.
- Acts as a liaison between benefit / risk management teams, issue management teams and internal as well as external customers (e.g., GPTs , TSB, Takeda Pharma PV, health authorities, vendors). Escalates significant safety issues to TSB, in collaboration with the VBU Global Medical Officer.
- Leads and coordinates the preparation of key documents, including benefit-risk management plans (RMPs), PSURs, DSURs and other benefit-risk evaluation statements and ad hoc reports (e.g., safety assessments of product quality issues, Health Hazard Evaluations HHEs), as well as the communication of key safety messages across the organization.
- Oversees and coordinates the development and maintenance of the Company Core Safety Information and all other Reference Safety Information (e.g., safety sections of IB and SPC) for all vaccine products in development and postmarketing (except for vaccines solely licensed in Japan).
- Ensures that the PV team prepares the medical and patient safety sections of all clinical trial documents (e.g., protocol, ICF, IB, CSRs) and other medical or patient safety documentation; signs off the core documents.
- Implements routine signal detection activities for vaccine products.
- In collaboration with Global Takeda PV responsible for maintaining oversight on vendor pharmacovigilance activities, on compliance-sensitive timelines (e.g., expedited reports), on safety training of the personnel involved in the Takeda vaccine trials, and on pharmacovigilance operations, incl. quality assurance and compliance.
- Represents PV physicians with respect to compounds in development and market drugs, safety monitoring and risk management assessment and analysis in Sr. Leadership, and GPT meetings
- Directs PV interactions with Regulatory authorities
- Guidance and verification of maintenance of the electronic system for storage and retrieval of safety data
- Guidance and verification of coding issues regarding SAEs and AEs / ADRs
- Resolving issues pertaining to medical queries
- Contributes to enhanced consistency in global pharmacovigilance processes in reviewing, generating and updating SOPs and working instructions concerning vaccine pharmacovigilance issues and cross functional procedures
- Training of company personal in pharmacovigilance to assure timely transmission of reported ADRs to pharmacovigilance department
- Ensures early assessment and communication to Senior Management on emerging potential safety issue
- Maintains own professional training up to date through self-learning, participation to external conferences, internal Company training plans and, where feasible, by teaching Pharmacovigilance and Pharmacepidemiology to Master and Postgraduates Students as well as to participants of continuous education courses.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Medically qualified, Medical degree or internationally recognized equivalent.
- Minimum of 10 years experience in pharmacovigilance, clinical research or clinical development, including a minimum of 4 years in a global pharmacovigilance organization. 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.
- Minimum of 5 years experience in people management and well-developed skills in teambuilding, motivating and developing people.
- Vaccines experience preferred