Manager, Office of Safety Operations (Remote) Bucharest

Manager, Office of Safety Operations (Remote)
Bucureşti
Bucharest, Bucharest, Romania

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 Abb
Vie.

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 Abbvie’s global clinical and
  - marketing case management processes, technology & training
  Implements new ICSR pharmacovigilance legislation into quality systems, metrics, technical requirements & training
• Leads effective
  - functional collaboration with an emphasis on building business relationships with relevant Abb
  Vie 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
  - 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
• Manages identification, prioritization, and timely resolution of potentially impactful issues, including clear communication and
  - up 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 Abb
  Vie 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 Abb
  Vie staff to execute the above responsibilities, including coaching/mentoring for staff performance and development (up to 5 people)

• Bachelor’s 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
  - party 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
  - functional matrix; seen as a collaborative partner within the organization
• Able to identify, assess, and effectively manage business and compliance risks
• Experience in leading
  - functional teams preferred
• Established influencing skills