Manager, Officer of Safety Operations

5 months ago

Toronto, Canada AbbVie Full time

**Company Description**
**Job Description** Purpose**:
This position 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.

**Responsibilities**:

- Designs and implements globally compliant and efficient ICSR pharmacovigilance processes, technologies & training
- Manages improvement of Abbvie’s global clinical and post-marketing case management processes, technology & training
- Implements new ICSR pharmacovigilance legislation into quality systems, metrics, technical requirements & training
- Leads effective cross-functional collaboration with an emphasis on building business relationships with relevant AbbVie stakeholders, including PPS, Commercial, GMA, RDQA, and Affiliates to establish and maintain harmonized ICSR processes
- Leads internal audits and external regulatory inspection activities; manages functional corrective and preventive action investigations
- Leads PPS’ understanding of the changing regulatory environment as it impacts ICSR management, process, technology, and people
- Leverages global data and cross-functional insights to optimize global ICSR operations including design of effective training approaches
- Manages process improvement initiatives with effective change management and rapid solutioning of unanticipated issues
- Drives identification, prioritization, and timely resolution of potentially impactful issues, including clear communication and follow-up across stakeholders through resolution, prevention, and trending
- Lead representative or SME on high impact/visibility projects with limited oversight
- Responsible as a leading member of the Office of Safety operations team for driving compliance and process business excellence for all ICSR PV activities
- Presents results to senior AbbVie stakeholders. Participates in governance meetings, and maintains strong working relationship with colleagues in PPS, RDQA, and Affiliate PV & Quality organizations
- Develops and manages a team of AbbVie staff to execute the above responsibilities, including coaching/mentoring for staff performance and development (up to 5 people)

**Qualifications** Qualifications**:

- Bachelor’s Degree or equivalent in related science field.
- 5 years pharmaceutical industry experience; including a minimum of 4 years in pharmacovigilance and/or pharmaceutical business operations
- Global experience preferred
- Experience in direct line management preferred
- Core knowledge of global Pharmacovigilance regulations (ICH, EMA, FDA) and the affiliate environment, with a firm understanding of related quality assurance systems
- Experienced in health authority inspections and/or internal or third-party audits
- Experienced in developing training & quality documents (SOP / Guidelines / CAPAs)
- Highly skilled in data interpretation; experienced with using excel
- Proficient in case processing processes, procedures, conventions
- Able to influence across stakeholders and manage within a cross-functional matrix; seen as a collaborative partner within the organization
- Able to identify, assess, and effectively manage

**Additional Information**
- 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. This job is eligible to participate in our long-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.

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