PV Risk Management Specialist

Baxter; Reading; On-site; GBP 50,000 - 70,000; Full time

Job summary

A global healthcare company is seeking a PV Risk Management Specialist in Reading, England. The role involves developing Pharmacovigilance Risk Management Plans (PV-RMPs) and requires expertise in regulatory requirements, excellent analytical skills, and a strong background in the pharmaceutical industry. The company values work-life balance and offers competitive compensation and professional development opportunities.

Benefits

Competitive total compensation package

Professional development opportunities

Work-life balance

Pension

Life Assurance

Qualifications

• Minimum two years’ prior pharmaceutical industry experience in Pharmacovigilance or Medical/Clinical functions.
• Knowledge of worldwide PV-RMP regulations, with prior EU regulations experience.
• Ability to independently lead long- and short-term project timelines.

Responsibilities

• Serve as primary author for PV-RMPs, preparing according to regulatory requirements.
• Facilitate cross-functional review and approval of PV-RMPs.
• Collaborate with country organizations on PV-RMPs and related activities.

Skills

Analytical thinking

Interpersonal communication

Scientific writing

Education

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

Job description

PV Risk Management Specialist

Join to apply for the PV Risk Management Specialist role at Baxter International Inc.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our colleagues are united by the mission to Save and Sustain Lives and are driven by a culture of courage, trust, and collaboration.

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.

Responsibilities

• 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.

Qualifications

• 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.

Benefits

• 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 the link here and let us know the nature of your request along with your contact information.

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Location: Reading, England, United Kingdom