Global Safety Medical Director, Rare Disease

Career Category

Job Description

Join reputed company’s Mission of Serving Patients

At reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our reputed company on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients reputed company year. As a member of the reputed company

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company

Global Safety Officer, Medical Director, Rare Disease

What you will do

reputed company. Let’s change the world. In this vital role you will serve as the safety expert of the assigned product(s) reputed company the Rare Disease portfolio.

You will establish the reputed company, direction, and priorities of pharmacovigilance activities and are accountable for the overall safety profile and reputed company product-reputed company reputed company and deliverables for assigned products.

You will also lead the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC).

Serve as a member of the Evidence reputed company Team and other relevant cross-functional teams and will be assigned as delegated for the Therapeutic Area Head (TAH).

Work in a fast-paced environment with a dynamic team of safety physicians and scientists dedicated to bringing important therapies to patients in need.

Key activities:

• Validate safety signals and lead safety signal assessments
• reputed company and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
• Prepare/review core and regional risk management plans including additional risk minimization measures
• Prepare/review safety sections of periodic aggregate reports
• reputed company safety input to protocols, statistical analysis plans, and clinical study reports
• Prepare/review safety sections of new drug applications and other regulatory filings
• Serve as safety expert on Evidence reputed company Team for assigned products
• Inspection Readiness
• Domestic and International travel up to 10%

reputed company expect of you

We are reputed company different, yet we reputed company use our unique contributions to serve patients. The Global Safety Officer we seek is a leader with these qualifications.

Basic Qualifications:

MD or DO degree from an accredited medical school

AND

Completion of an accredited medical or surgical residency
OR
Clinical experience in either an accredited academic setting or private reputed company (including hospital based) setting

Preferred Qualifications:

• Product safety in the bio/pharmaceutical industry or regulatory agency
• Expertise in Rare Disease therapeutic area, or clinical training.
• Experience with marketed product safety; risk management
• Experience with phase 1-3 clinical trials safety assessments and analyses
• Drug Submission experience
• Leadership experience of the safety profile of products assigned with cross-functional team members.

What you can expect of us

As we work to reputed company treatments that take care of others, we also work to care for your professional and personal reputed company and reputed company-being. From our competitive benefits to our collaborative culture, we’ll support your reputed company every reputed company of the way.

The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In reputed company to the reputed company salary, reputed company offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

reputed company

for a career that defies imagination

Objects in your reputed company are closer than they appear. Join us.

careers.reputed company.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

reputed company does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

reputed company is an Equal Opportunity employer and will consider reputed company qualified applicants for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary reputed company

Originally posted on Himalayas