PV Operational Team Lead

Helsinki, fi

• Function: Research & Development
• Job Type: Full-time

Job ID: R00133736
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.
Job Description

QUALIFICATIONS

• Bachelor’s degree or higher in life sciences, pharmacy, medicine, or a related field; additional scientific or regulatory training is an asset.
• Minimum 4–6 years of experience in pharmacovigilance or a related field, including oversight of PV operational and compliance metrics.
• At least 2–3 years of people management experience for medium to large teams.
• Proven experience with quality management systems, audits, and CAPA processes.
• Strong leadership with a proactive, independent approach and ability to work effectively within a matrix and cross-functional environment.
• Excellent organizational, planning, and communication skills, along with sound judgment and attention to detail.
• Strong commitment to compliance with all relevant rules and procedures.
• Fluency in English and Finnish required;
• Good understanding of Swedish is also required;
• Commitment to ongoing professional development and demonstrated ability to thrive in a dynamic environment focused on patient safety and care.
  Additional Information
  Interested? Please fill in your application and CV into our recruiting system at the latest by 21st of September 2025.
  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.
  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 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.htm

• Coordinate, track, and report metrics to ensure oversight of PV system activities, maintaining full compliance with local regulations and AbbVie’s internal standards.
• Oversee delegation of PV tasks, ensuring appropriate supervision and documentation.
• Develop, maintain, and evaluate local and regional quality procedures in line with corporate and country-specific requirements; support PV exception reporting, CAPA processes, and business continuity planning.
• Lead Individual Case Safety Report (ICSR) management, including case recording, follow-up, expedited reporting, literature reviews, and quality control.
• Coordinate preparation, submission, and documentation of periodic safety reports (PSURs), annexes, and related safety deliverables for the Regional PV team.
• Partner with the Regional PV Lead to manage and support internal audits, service provider audits, and regulatory PV inspections; coordinate CAPA development and timely completion of actions.
• Ensure PV requirements are met for all activities involving the identification and handling of safety information, maintaining alignment with both corporate and local standards.
• Oversee PV training compliance, maintain the PV Training Matrix, and develop additional training materials as needed.
• Monitor and evaluate the impact of local and regional PV-related legislation, updating processes and procedures as necessary.
• Monitor, assess, and communicate on local safety data, collaborating with the Product Safety Team and key stakeholders to address issues and concerns.
• Ensure after-hours availability and maintain disaster recovery and business continuity plans for critical PV processes.
• Lead recruitment, onboarding, coaching, performance management, and succession planning for your team.
  Qualifications