Vaccine Pharmacovigilance Benefit-risk Scientist

vor 21 Stunden

Basel, Schweiz Takeda Pharmaceutical Vollzeit

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a **Vaccine Pharmacovigilance Benefit-Risk Scientist** in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.**

The Vaccine Pharmacovigilance Benefit Risk Scientist provides support to Takeda’s Vaccine Pharmacovigilance department in the monitoring of the safety profile of assigned vaccine products within agreed timeframes and to a high standard of accuracy, in compliance with Takeda’s business rules, standard operating procedures and regulatory requirements.

In this role, you will work in a dynamic environment and support developmental programs, as well as launch
- and post-authorization activities, as required for the assigned vaccine product(s). You will support the global Vaccine Safety Lead for signal and pharmacovigilance (PV) life-cycle management and will be involved in a broad variety of PV and clinical safety activities including, but not limited to:

- Review, analysis, and presentation of safety data
- Perform signal detection and evaluation
- Prepare or review Aggregate Reports (PSURs, DSURs) and Ad Hoc Safety Reports (e.g., Health Hazard Evaluations)
- Support the preparation of clinical study documents, as well as regulatory submission documents
- Prepare, in close collaboration with cross functions, responses to Health Authority questions
- Provide input into responses to inquiries from internal sources, health care professionals, and other external sources
- Support the development and maintenance of the Reference Safety Information (e.g., Company Core Safety Information DCSI / CCSI)
- Support the preparation and maintenance of Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategies (REMS)
- Review and perform 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.
- Provide support, as required, for licensing activities, regulatory authority inspections, company audits, and for project product recall activities
- Perform PV training and mentoring of internal and cross-functional team members.
- Participate as a PV expert in cross-functional teams, DMC meetings, Investigator meetings, as applicable

**Education**: Advanced life science degree (e.g., MSc or internationally recognized equivalent)

**Skills**:

- 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

**Desired characteristics**:

- Proven collaborative internal relations with Clinical Development, Regulatory Affairs, Medical Affairs, Quality and Legal Counsel
- High integrity, sense of urgency, ability to recognize time sensitivity, willingness to be a "player/coach"
- Excellent English written and verbal communication skills, additional languages (e.g., Spanish, Japanese, German) desired
- Dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging circumstance
- Demonstrated success in building effective matrix working teams, systems, and processes; proven ability to identify, select and manage a variety of external resources

**WHAT TAKEDA CAN OFFER YOU**

At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver **_Better Health and a Brighter Future _**to people around the world.

**Empowering Our People to Shine**

**Locations**:
Zurich, Switzerland

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

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