Senior Principal Pharmacovigilance Scientist

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The Future Begins Here

At Takeda we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities we are meeting the need of patients our people and the planet.

Bengaluru the city which is Indias epicenter of Innovation has been selected to be home to Takedas recently launched Innovation Capability Center. We invite you to join our digital transformation this role you will have the opportunity to boost your skills and become the heart of an innovative engine that is contributing to global impact and improvement.

At Takedas ICC we Unite in Diversity

Takeda is committed to creating an inclusive and collaborative workplace where individuals are recognized for their backgrounds and abilities they bring to our company. We are continuously improving our collaborators journey in Takeda and we welcome applications from all qualified candidates. Here you will feel welcomed respected and valued as an important contributor to our diverse team

About the role:

The Senior Principal Pharmacovigilance Scientist ensures regulatory compliance and safety of Takedas products by managing large projects developing innovative solutions and leading cross-functional teams. This role contributes to the development and execution of pharmacovigilance strategies ensuring patient safety and regulatory adherence.

The role represents pharmacovigilance regionally and globally as an authoritative member of Global Program Teams and subteams and coordinates signal detection safety surveillance and safety review activities for assigned products.

How you will contribute:

Facilitate ongoing safety surveillance for assigned products assisting with or leading data collection and assessment for PSPV Safety Team and Safety Management Team activities.

Coordinate and perform signal identification evaluation and management activities for assigned products.

Assist with or lead authorship of safety evaluations define scope and methodology and provide background information for aggregate safety reports.

Conduct preliminary safety analyses and prepare ad hoc safety reports including health hazard evaluations signal evaluation reports and health authority responses.

Partner with Safety Management Team colleagues and contribute to safety-related deliverables associated with new drug applications benefit-risk assessments and risk minimization activities including risk management plans.

Liaise with colleagues inside and outside PSPV to gather and provide input for critical documents including protocols amendments informed consent forms investigator brochures core data sheets IMPDs clinical study reports INDs NDAs BLAs and CTAs.

Liaise with relevant functional areas inside and outside global PV to support efficient timely compliant and patient-focused safety data generation.

Represent pharmacovigilance in cross-functional teams committees and external environments at global and regional levels as required.

Assist with or lead preparation and presentation of identified and potential patient safety risks and Safety Management Team recommendations to decision-making bodies such as the Takeda Safety Board.

Build and maintain in-depth knowledge of designated products and studies and close knowledge of protocols to respond effectively to safety issues.

Ensure up-to-date representation of safety information in Company Core Data Sheets Reference Safety Information Investigator Brochures and other labeling documents.

Demonstrate outstanding knowledge of local and global health authority requirements.

Support maintenance of a highly effective global safety organization in full compliance with worldwide regulations.

Lead cross-functional teams effectively fostering a collaborative environment and mentoring newly hired peers and incumbent PV Scientists.

Education and Experience

A Medical scientific pharmacy nursing life sciences or related degree is required with 8 years of relevant experience.

Excellent working understanding of safety database configuration and adverse event coding to direct advanced searches.

In-depth knowledge of clinical trial methodology pharmacovigilance regulations safety data analysis benefit-risk assessment and drug development.

Strong critical and analytical thinking and project management skills.

Ability to review analyze interpret and present complex data to a high standard with strong attention to detail.

Proficient communication skills with the agility to respond clearly and concisely to different audiences.

Team-oriented approach and ability to work effectively in a fast-paced cross-functional environment.

Strong organizational skills and ability to prioritize independently with minimal supervision.

Ability to coordinate moderate and clearly document conclusions of cross-functional scientific meetings.

BENEFITS:

It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:

• Competitive Salary Performance Annual Bonus
• Flexible work environment including hybrid working
• Comprehensive Healthcare Insurance Plans for self spouse and children
• Group Term Life Insurance and Group Accident Insurance programs
• Employee Assistance Program
• Broad Variety of learning platforms
• Diversity Equity and Inclusion Programs
• Reimbursements Home Internet & Mobile Phone
• Employee Referral Program
• Leaves Paternity Leave (4 Weeks) Maternity Leave (up to 26 weeks) Bereavement Leave (5 calendar days)

ABOUT ICC IN TAKEDA:

• Takeda is leading a digital revolution. Were not just transforming our company; were improving the lives of millions of patients who rely on our medicines every day.
• As an organization we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.