Senior Analyst - Office of Safety Operations (Remote - US, UK, Germany or Romania)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

The Senior Analyst - Office of Safety Operations supports the Safety Operations organization to achieve its mission of improving patient lives by delivering high quality, and timely adverse event management and through driving industry leading ICSR operations, ICSR standards and technology at AbbVie.

Core Job Responsibilities include:
• Supports the establishment of compliant and efficient ICSR pharmacovigilance processes, technologies & training at AbbVie; seen as a subject matter expert (SME)
• Supports improvement of Abbvie's global clinical and post-marketing case management processes, technology & training
• Supports the implementation of new ICSR pharmacovigilance legislation into quality systems, metrics, technical requirements & training
• Drafts or contributes significantly to job aids, work instructions and SOPs.
• Co-ordinates and develops materials and delivers training (through multiple modalities)
• Works' cross-functionally with AbbVie stakeholders, including PPS, Commercial, GMA, RDQA, and Affiliates to establish and maintain harmonized and efficient ICSR processes
• Supports internal audits and external regulatory inspection activities as SME; supports functional corrective and preventive action investigations
• Leverage's insights to optimize global ICSR operations including design of effective processes & training
• Supports process improvement initiatives with effective change management and robust solutioning of unanticipated issues
• Supports identification, prioritization, and timely resolution of potentially impactful issues, including clear communication and follow-up across stakeholders through resolution, prevention, and trending
• Responsible as a member of the Office of Safety operations team for driving compliance and process business excellence for all ICSR PV activities
• Presents results to AbbVie stakeholders. May participate in governance meetings, and maintains strong working relationship with colleagues in PPS, RDQA, and Affiliate PV & Quality organizations
• Representative or SME on high impact/visibility projects with limited oversight
• Clear, succinct communication and appropriate level of customer service with both internal and external customers

Qualifications

Minimum Qualifications:

• Bachelor's Degree or equivalent in related science field.
• 4+ years pharmaceutical industry experience
• 2+ years in pharmacovigilance, quality systems and/or training operations

Preferred Qualifications:

• Global experience preferred

Other Required Skills:
• Solid knowledge of global Pharmacovigilance regulations (ICH, EMA, FDA) and the affiliate environment, with a good understanding of related quality assurance systems
• Experienced in preparing for and participating in health authority inspections and/or internal or third-party audits
• Experienced in developing training & quality documents (SOP / Guidelines / CAPAs)
• Experienced in data interpretation; experienced with using excel

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html