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Lead Rems Specialist Safety Surveillance

Company

Viatris

Address , Remote
Employment type FULL_TIME
Salary $66,000 - $127,000 a year
Expires 2023-12-07
Posted at 8 months ago
Job Description
1100 Mylan Pharmaceuticals Inc.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:
  • Partnership – Leveraging our collective expertise to connect people to products and services.
  • Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
  • Access – Providing high quality trusted medicines regardless of geography or circumstance;
Every day, we rise to the challenge to make a difference and here’s how the Lead REMS Specialist, Safety Surveillance role will make an impact:
Key responsibilities for this role include:
  • Identify and communicate REMS safety-related program changes to relevant stakeholders.
  • Serve as Viatris representative on REMS sub-team safety meetings.
  • Assist with duties of the single point of contact for REMS programs.
  • Review and approve REMS assessments with a focus on safety-related data.
  • Collaborate with safety sub-team colleagues to satisfy health authority requests while representing Viatris interests.
  • Author SOPs as needed/requested by PSRM management. Review existing SOPs and author updates as required.
  • Review and monitor regional risk management programs.
The minimum qualifications for this role are:
  • Proficiency in speaking, comprehending, reading, and writing English is preferred.
  • Minimum of a Bachelor's degree (or equivalent) in the life sciences and 3-5 years of experience. However, a combination of experience and/or education will be taken into consideration.
  • Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
  • Medical related license preferred (i.e., RN or Pharm.D).
  • Ability to add, subtract, multiply, and divide.
  • Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
  • Must possess a strong clinical and scientific background. Must be familiar with local, regional, and global pharmacovigilance regulations.
  • May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Normal office situation.
  • Periodic travel is required.
  • Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping.
  • Must possess strong and effective verbal and written communication, skills, and time management skills. Must possess computer skills by using MS Word, Excel, and Outlook.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $66,000 - $127,000.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
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