Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Manager Global Pharmacovigilance
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives, and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
- Vacation – 3 weeks accrued vacation (1st yr. is prorated) vacation buy program 3 personal days 10 paid holidays
- Company Paid Pension Plan
- 401(k) retirement savings with a generous company match of 5%
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
The Opportunity
This position works out of our Columbus, OH and/or Abbott Park, IL location in the Nutrition Division.
The Opportunity:
As a Medical Safety & Surveillance (MSS) Global Pharmacovigilance Manager, the candidate will use his/her in-depth understanding of pharmacovigilance to ensure compliance with regulatory requirements for Abbott Nutrition products registered as drugs. The MSS Global Pharmacovigilance Manager will have responsibility for Abbott Nutrition’s global pharmacovigilance system, including development and implementation of global standardized operating procedures. The candidate will also lead the development/maintenance of local pharmacovigilance systems (predominantly for countries in Latin America), ensuring compliance with local regulations. The candidate will have departmental, cross functional, and global influence, and will be considered a pharmacovigilance subject matter expert within the company.
What You’ll Work On
- Organizes, manages and maintains a highly compliant global pharmacovigilance system for Abbott Nutrition
- Maintains awareness and ensures compliance with established and updated local and global pharmacovigilance processes as well as local and global regulations and guidelines for pharmacovigilance
- Develops and implements training programs for individuals involved in pharmacovigilance activities
- Monitors pharmacovigilance system performance; tracks compliance metrics and reports to global MSS Leadership Team
- Ensures global/local pharmacovigilance audit readiness; Supports pharmacovigilance audits/inspections and leads activities related to corrective and preventative actions for any audit findings
- Actively contributes to activities related to the monitoring of safety profiles for Abbott Nutrition products registered as drugs, such as signal detection, evaluation, and prioritization
- Provides oversight of entry of data into the safety database; ensures data is accurate and complete
- Assists local staff with drafting and implementation of Safety Data Exchange Agreements
- Works cross-functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into practices and procedures
- Assists in the preparation, review and submission of aggregate safety reports
- Accountable for strategic pharmacovigilance activities for the division
Education and Experience You’ll Bring
Required:
Education:
- Master’s degree in related health science or equivalent skills, education, or experience.
Preferred
- 5-7 years of experience and proficiency in drug safety/pharmacovigilance and in the development and implementation of compliance processes in a pharmacovigilance setting
- Solid understanding and working knowledge of pharmacovigilance regulatory requirements
- Strong medical knowledge and understanding to support safety related activities; background/experience with nutrition/nutritional products is a plus
- Minimum 3 years of experience in leading complex projects or programs; global/regional experience desirable
- Fluency in spoken/written English; Fluency in spoken/written Spanish is a plus.
- Computer proficient (Windows, Word, Excel); experience working in adverse event databases
- Excellent communication and interpersonal skills, both written and spoken.
- Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects
- Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity
- High level of accountability and reliability
- Demonstrates ability to work productively as a team
- Ability to work in a fast paced, changing environment
- Ease of operating in high stress, big decision situations
- Continuous improvement mindset
- Ability to influence a team in a positive way in relation to performance, change, and culture
- Demonstrate broad knowledge of Abbott’s business and how department processes/responsibilities interconnect
- Mastery of the inventory deployment planning process
- Exceptional problem-solving skills
Apply Now
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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