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Manager, Pv

1-5 years
Not Disclosed
10 Sept. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Baxter: Where You Save and Sustain Lives

At Baxter, we are united by a mission that impacts lives around the globe. Every role within our organization contributes to improving health outcomes for millions of patients, fostering a profound sense of purpose.

For over 85 years, Baxter has been a pioneer in medical innovations, with products and therapies used in hospitals, clinics, and homes worldwide. Together, we create an environment where we inspire one another to do our best work.

About the Role

We are seeking a leader to join the Safety Operations team within Global Patient Safety (GPS). This position will oversee one or more areas within GPS, managing team workflows and training activities for all direct reports.

Essential Duties and Responsibilities

  • Operational Management:
    Oversee daily operations for assigned staff and/or outsourced vendors.

  • Team Leadership:
    Provide direct oversight, including mentoring, performance management, and staffing decisions.

  • Collaboration:
    Develop strong working relationships across Baxter business groups.

  • Quality Control Oversight:
    Review quality control metrics and compliance reports, and develop corrective action plans as needed.

  • Meeting Participation:
    Participate in and lead meetings to facilitate communication and alignment.

  • Expertise Development:
    Establish expertise in handling sensitive staff and customer issues, including interactions with regulatory agencies.

  • Communication:
    Keep the team informed of departmental and functional priorities through regular updates.

  • Regulatory Support:
    Assist with regulatory inspections (FDA, EMEA) and internal audits.

  • Cross-Functional Representation:
    Represent Global Pharmacovigilance on cross-functional teams and participate in CAPA efforts.

  • Additional Responsibilities:
    Take on other tasks and projects as assigned.

Qualifications

  • Leadership Skills:
    Ability to effectively manage and lead team members.

  • Training Ability:
    Experience in developing and training staff.

  • Communication Skills:
    Excellent oral and written communication skills.

  • Interpersonal Skills:
    Strong skills to foster teamwork and collaboration.

  • Medical Knowledge:
    Solid understanding of medical and clinical practices.

  • Attention to Detail:
    Exceptional focus on accuracy and detail.

  • Regulatory Knowledge:
    Familiarity with drug safety and pharmacovigilance regulatory guidelines.

Education and Experience

  • Degree:
    Bachelor’s degree in Nursing, Pharmacy, Science, or a related field.

  • Management Experience:
    Minimum of 1 year in a management role.

  • Industry Experience:
    At least 5 years of experience in Pharmacovigilance or a related discipline.

  • Regulatory Expertise:
    Strong understanding of global pharmacovigilance regulations, processes, and requirements.

Reasonable Accommodations

Baxter is committed to providing reasonable accommodations for individuals with disabilities. If you require assistance during the application or interview process due to a medical condition or disability, please click here to inform us of your needs along with your contact information.

Recruitment Fraud Notice

Baxter has identified incidents of employment scams where fraudulent parties impersonate Baxter employees or recruiters to obtain personal or financial information. To protect yourself, please review our Recruitment Fraud Notice.

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