Job Details

ID #44335845
State Missouri
City Helena
Full-time
Salary USD TBD TBD
Source Takeda Pharmaceuticals
Showed 2022-07-24
Date 2022-07-24
Deadline 2022-09-22
Category Et cetera
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Medical Director, Pharmacovigilance, NeuroScience

Missouri, Helena, 64459 Helena USA

Vacancy expired!

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Director, Pharmacovigilance, NeuroScience, in our Cambridge, Massachusetts office or virtually.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.Here, you will be a vital contributor to our inspiring, bold mission.As a Medical Director, Pharmacovigilance, NeuroScience, working on the Global Patient Safety and Evaluations team, you will be empowered to serves as a Global Safety Lead (GSL) and Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product.OBJECTIVE:Serves as a senior-level Global Safety Lead (GSL) and Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product.

Depending on resource allocations, may directly manage a group of GSLs and PV Scientists responsible for overseeing the medical safety profile for assigned products.

Interacts with and influences colleagues from other functions to ensure the successful development, design and implementation of comprehensive safety and benefit-risk assessment strategies for products.

Oversees signal detection and risk management activities for assigned products and ensures that development plans include comprehensive safety assessment plans.

ACCOUNTABILITIES:Leads Global Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products.

Represents the cross-functional program team as a product safety profile and risk mitigation expert for internal (e.g., Takeda Safety Board) and external (e.g., Independent Data Monitoring Committee) stakeholders.

Manages cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.

Leads the interpretation of safety data from internal and external sources, assessment of ensuing scientific and medical implications, and communication of the impact of same both in terms of “go/no go” decisions or modification of development plan or study design, including potential impact on timeline or product labeling, ensuring the primacy of patient safety.

Mentors GSLs and PV Scientists with respect to compounds in development and marketed drugs, safety monitoring and risk management assessment and analysis.

Supports cross-functional team evaluations in preparation for presentations to the Takeda Safety Board and similar forums. The Medical Director will be a key player in the preparation and presentation of materials to the Takeda Safety Board and similar forums.

Manages the reactive response to emerging safety signals.

May perform the medical safety evaluation of projects for new business development opportunities (e.g., due diligence evaluations).

Ensures high quality analyses of safety information, in support of safety update regulatory submissions, investigational and new drug applications and interactions with regulatory authorities worldwide.

Assists the Global Medical Safety Therapeutic Area Head in assessing the implications of emerging regulatory intelligence and developing strategies for adapting processes and procedures.

Oversees risk management plans for compounds in development and marketed drugs.

Ensures that GSLs are proactively identifying safety concerns and developing contingency strategies that address these challenges.

Maintains professional knowledge and accreditation by active participation in continuing medical education activities, and fosters a community of continual learning.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:Medical Degree (M.D. or D.O.) or internationally recognized equivalent, with direct clinical patient care experience following post-graduate training and appropriate grounding and knowledge of general medicine. Board certification and licensure preferred.

Minimum of 5 years experience in the pharmaceutical industry within Drug Safety/Pharmacovigilance, with both investigational and marketed products.

At least 3 years of experience with aggregate reporting, safety surveillance, signal management and/or risk management.

Proven ability to work in an international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills.

Base Salary Range: 217,000 to 310,000 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.WHAT TAKEDA CAN OFFER YOU:401(k) with company match and Annual Retirement Contribution Plan

Tuition reimbursement

Company match of charitable contributions

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

“This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.”Empowering Our People to ShineLearn more at takedajobs.comTakeda 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.#LI-NS1EEO StatementTakeda 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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time#LI-Remote

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