Takeda Pharmaceuticals Hiring for Associate Director, Lead Pharmacovigilance Scientist at Atlanta Full Time

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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as an Associate Director, Lead Pharmacovigilance Scientist where you will provide strategic leadership and safety expertise, including support for regulatory submissions and responses, aggregate reports, and white papers. You will also act as an expert from safety science perspective in oncology. As part of the Oncology Medical Safety team, you will report to Senior Medical Director, PV, Oncology.

How you will contribute:

• Serve as the Global Safety Lead

• Responsible for reviewing, analyzing, and interpreting information from ongoing clinical and non-clinical studies alongside the assessment of ensuing scientific and medical implications of making recommendations based on new safety information for both developmental compounds and marketed drugs to ensure the primacy of patient safety

• PV science expert for designated compound(s) within primary therapeutic as appropriate oversees safety and process activities within these therapeutic areas.

• Integral to GST and GCDT and assisting with writing/reviewing of aggregate reports including the RMP.

• Direct, mentor, and develop PV Science colleagues commensurate with his/her experience.

• Ability to functions as senior contact for safety related matters to cross functional groups and external bodies.

• Maintains compound and more general safety expertise

• Provides strategic and technical expertise and leadership. Sets medical, scientific and process standards for all products within these therapeutic areas.

• Contributes to clinical program and protocol design, safety risk management, signal detection.

• Oversees PV reports and submissions in designated therapeutic area(s), e.g., aggregate reports and regulatory submissions.

• In collaboration with the PV TA Lead, leads evaluation and management of emergent safety issues.

• Ensures adequate internal support and external resourcing (CRO & BPO) to deliver all safety reports.

• Ensures adequate distribution of assignments and prioritization of tasks within the PV specialist’s staff.

• Interfaces with functional areas within and outside PV.

Minimum Requirements/Qualifications:

• Bachelor’s degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, PhD, and PharmD).

• Minimum 8 years experience in Pharmacovigilance with experience preparing regulatory documents.

• Comprehensive understanding of PV process in aggregate submissions and the new regulations that have been established.

• Demonstrated experience in people management and well-developed skills in team building, motivating and developing people.

• Expert knowledge of clinical trial and pharmacovigilance methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements

• Excellent organization skills and ability to prioritize individual and team work loads.

• Excellent written and oral communication skills including ability to present to large internal/external groups

• Capability to synthesize and analyze data from multiple sources.

• Expertise in pre and post marketing SD. .

• Demonstrated leadership skills with proven ability to motivate and work in multidisciplinary teams.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.

Base Salary Range: $143,000 to $205,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado’s Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts – Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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