PV Risk Management Specialist

Baxter International; Reading; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading healthcare company in Reading is seeking a PV Risk Management Specialist to manage Pharmacovigilance Risk Management Plans for drug and biologic products. The ideal candidate will have a Bachelor's degree in a related field and a minimum of two years' experience in Pharmacovigilance. Responsibilities include authoring PV-RMPs, facilitating regulatory approval, and managing project timelines. Benefits include a competitive compensation package and professional development opportunities.

Benefits

Competitive total compensation package

Professional development opportunities

High importance placed on work life balance

Pension

Life Assurance

Qualifications

• Minimum two years’ pharmaceutical industry experience in Pharmacovigilance or Medical/Clinical functions.
• Knowledge of worldwide PV-RMP regulations, with European Union (EU) regulations required.
• Ability to independently lead project timelines and deliverables.

Responsibilities

• Serve as primary author for PV-RMPs, ensuring compliance with regulatory requirements.
• Facilitate cross-functional review and approval of PV-RMPs.
• Manage project timelines for preparation and submission of PV-RMPs.

Skills

Analytical skills

Communication skills

Scientific writing

Education

Bachelor’s degree in nursing/biologic/medical/clinical field

Advanced degree

Job description

This is whereyour work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

We develop quality products with the patient in mind, so our Risk Management function are also patient-centric. That means you can be proud of our work and the value we provide to people every day.

As the PV Risk Management Specialist you will be part of the Risk Management function within the GPS organization, responsible for development and management of Pharmacovigilance Risk Management Plans (PV-RMPs) to support Baxter’s drug and biologic products.

What you'll be doing:

• Serve as primary author for PV-RMPs, applying various regional/local/company templates and ensuring all PV-RMPs are prepared according to regional/local regulatory requirements.
• Facilitate cross-functional review and approval of PV-RMPs.
• Respond to queries/requests from regulatory authorities regarding PV-RMPs.
• Independently handle project timelines associated with preparation and submission of PV-RMPs.
• Represent GPS Risk Management on cross-functional teams.
• Collaborate with country organizations in developing and leading PV-RMPs and associated commitment activities.
• Assist RM manager/commitment tracking tool owner with planning and oversight of PV-RMP commitments.

What you'll bring:

• Bachelor’s degree in nursing/biologic/medical/clinical field; advanced degree and prior clinical practice experience is desired.
• Minimum two years’ prior pharmaceutical industry experience in Pharmacovigilance or Medical/Clinical functions.
• Knowledge of worldwide PV-RMP regulations: prior experience with European Union (EU) regulations is required. Experience with other regional/local regulations is desired.
• Excellent analytical and critical thinking skills.
• Excellent oral, written, and interpersonal communication skills, including ability to lead cross-functional group discussions and meetings.
• Scientific/clinical knowledge and excellent scientific writing skills.
• Ability to independently lead long- and short-term project timelines and deliverables.
• Exposure to working relationship with regulatory authorities.

What are some of our benefits of working at Baxter?

• Competitive total compensation package
• Professional development opportunities
• High importance placed on work life balance
• Pension
• Life Assurance

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.