Takeda Pharmaceuticals Medical Director, Pharmacovigilance, GI in Charleston, West Virginia
About the role:
Join Takeda as a Medical Director, PV, GI where you will support developmental programs, including both early and late-stage development. You will also manage the oversight of signal detection and risk management activities for designated global/regional product(s), together with the global safety lead responsibly.
You will also be responsible for line management responsibilities for junior physicians and/or scientists and support compounds/initiatives outside of the primary therapeutic area(s) as directed by business and departmental needs. As part of the Global Patient Safety and Evaluations team, you will report to Executive Medical Director, Pharmacovigilance - GI, and work with the global medical safety teams.
How you will contribute:
The expectation of the Global Safety Lead role for compound(s) both in development and marketing in close association with the Therapeutic Area Lead.
Company-wide safety expert for your compound responsibilities.
Intimate knowledge of safety, including any latest safety concerns and risk/benefit profile for 'own' compounds with input for other compounds.
Serve in a leadership capacity for complex and important programs.
Responsible for the development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs, etc.
Mentoring of Pharmacovigilance Physicians and Specialists.
Perform activities required to serve as a Global PV physician:
Review and oversight of safety data, both non-clinical and clinical
Review and/or approval of protocols, SAPs, clinical study reports, IBs, IMPD, and other documents developed for submission to regulatory authorities
Interactions with external experts and regulatory agencies and partner companies
Review safety data and participate in dose escalation decisions
Authorship and sign-off of the Safety Monitoring Plan/Risk Management Plan
Qualified physician (Licence, e.g. GMC registered, preferred).
Minimum of 8 years experience in pharmacovigilance, clinical research, or clinical development.
2+ years of clinical experience with patients following post-graduate training with knowledge of general medicine.
Knowledge of principles of epidemiology and statistics.
Critical thinking and analytical skills.
Excellent oral and written communication skills including the ability to present to large internal/external groups.
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 a company match of charitable contributions
Family Planning Support, Family Leave
Flexible Work Paths
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: $ 217,000 to $ 310,000, based on the candidate's 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. 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.
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.
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