Senior Principal Pharmacovigilance Scientist

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Job Description

About the role:

The Pharmacovigilance Scientist, Senior Scientist ensures regulatory compliance and safety of Takeda's products by managing large projects, developing innovative solutions, and leading teams. This role contributes to the development and execution of pharmacovigilance strategies, ensuring patient safety and regulatory adherence.

How you will contribute:

* Manage large pharmacovigilance projects or processes with limited oversight

* Develop and implement risk management strategies for complex situations

* Lead the preparation and review of detailed safety reports

* Conduct signal detection and safety assessments independently

* Engage with stakeholders and regulatory authorities, providing authoritative advice

* Lead and mentor junior staff, fostering a collaborative environment

* Deliver training on pharmacovigilance practices to enhance team capabilities

Skills and qualifications:

* Applies comprehensive risk management strategies in complex situations, capable of advising others

* Recognized as an expert in pharmacovigilance, able to develop strategic safety initiatives and coach others

* Ensures regulatory compliance with a deep understanding of safety regulations and guidelines

* Proficient in safety reporting and able to lead the preparation of detailed reports

* Conducts signal detection and safety assessments independently, providing critical analysis

* Experienced in clinical development, contributing to the strategic planning and execution of clinical trials

* Engages effectively with stakeholders and regulatory authorities, providing authoritative advice

* Leads teams effectively, fostering a collaborative environment and mentoring junior staff

* Delivers training on pharmacovigilance practices, enhancing team capabilities

* Communicates complex safety data clearly and effectively to various audiences

* Analyzes safety data meticulously to make informed decisions

* Demonstrates strong decision-making skills in high-stake environments

As an expert professional within the organization, you develop innovative solutions to complex problems aligned with organizational objectives. Your work involves addressing intricate issues, requiring in-depth analysis and judgment. You also engage with key contacts outside your expertise area and contribute to the development of new concepts and standards. Operating with considerable autonomy, you serve as a consultant to management and an external spokesperson on major matters, often working independently and leading function teams or projects. Additionally, you play a role in training and mentoring junior staff.

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