Manager, Office of Safety Operations (Remote)
Manager, Office of Safety Operations (Remote)
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Job Description
- Located Home or Office Based in Romania
- Please note salary range provided is relevant to the US location only
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.
The Manager Office of Safety Operations sits in the ICSR Compliance department within the Safety Operations function.
This position is responsible for monitoring and ensuring compliance with the global regulatory reporting of ICSRs. The role includes management of investigations to address compliance deviations and drive continuous improvement as well as managing license partners to ensure alignment on reporting obligations and safety data exchange requirements.
The successful candidate will also support internal and external audits and regulatory inspections by leading in the front room providing documentation data analysis and subject matter expertise related to ICSR processes
Responsibilities:
- Designs and implements compliant and efficient ICSR pharmacovigilance processes technologies & training
Leads improvement of Abbvies global clinical and postmarketing case management processes technology & training
Implements new ICSR pharmacovigilance legislation into quality systems metrics technical requirements & training - Leads effective crossfunctional 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; supports functional corrective and preventive action investigations - Supports PPS understanding of the changing regulatory environment as it impacts ICSR management process technology and people
Leverages global data and crossfunctional 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 - Manages identification prioritization and timely resolution of potentially impactful issues including clear communication and followup across stakeholders through resolution prevention and trending
Responsible as a senior 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. May participate 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 :
- Bachelors Degree or equivalent in related science field. 5 years pharmaceutical industry experience; including a minimum of 3 years in pharmacovigilance
Global experience - 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 thirdparty audits
- Experienced in developing training & quality documents (SOP / Guidelines / CAPAs)
- Skilled in data interpretation; experienced with using excel
- Proficient in case processing processes procedures conventions
- Able to influence across stakeholders and manage within a crossfunctional matrix; seen as a collaborative partner within the organization
- Able to identify assess and effectively manage business and compliance risks
- Experience in leading crossfunctional teams preferred
- Established influencing skills
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Yes
Employment Type :
Fulltime
Employment Type
Remote
