Drug Safety Manager
4 days ago
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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.
Job DescriptionLocation
This position can be located in Sweden, Norway or Denmark. You report to Head of affiliate Pharmacovigilance & Medical Info and is part of the Scandinavia Pharmacovigilance & Medical Info team. After June 1st you will report into the Regional PV Lead located in Netherlands.
Tasks
As a Drug Safety Manager you will collaborate to fulfil the responsibility for the coordination and execution of different aspects of affiliate pharmacovigilance (PV) to ensure that all responsibilities & regulations are met. Contributing to protecting our patients and striving to being a World-Class Safety organization. You will work in a Scandinavian role, hence able to manage PV tasks for four different countries Denmark, Sweden, Norway and Iceland.
- Main tasks are to collect, assess, categorize and follow up Adverse Event reports from various sources such as HCPs, patients, Patient support programs, vendors, IIS and reporting of these to AbbVie global PV department. Also conduct Quality checks for colleague report and training of new PV staff/contractors if required.
- Educate colleagues and external partners.
- Support with the Pharmacovigilance requirements of Patient support programs, market research, social media & webpages.
- Continuously work with quality mindset and improvement focus and strive for better efficiencies for all processes.
- Work towards a great collaboration with other departments within the affiliate, vendors and global PV colleagues.
- Support in audits and inspections.
We are looking for someone who has a positive attitude, is a fast learner, pro-active and solution oriented. Be able to work independently but also be a prestige less team player. Good at seeing the big picture and having a risk-based approach, however also work with details in complex processes.
Qualifications- Degree in Life Science (Bachelor or MSc. in Pharmacy or equivalent).
- Language skills: Fluent in Swedish, Norwegian, or Danish; excellent in English.
- Experience in Pharmacovigilance is preferred, but experience in other areas such as Regulatory Affairs, Medical Affairs, Quality Assurance, or Clinical Trials can also be considered.
- Ability to quickly learn and work comfortably in different electronic data systems.
- Strong commitment to compliance with relevant regulations, procedures, and scientific quality and integrity.
- Ability to thrive in a changing environment and re-prioritize workload according to business needs.
- Detail-oriented, yet able to work efficiently and structure tasks to meet tight deadlines.
- Solution-oriented mindset and high accountability.
- Good communication skills, both verbal and written.
- Good team player who can also work independently.
AbbVie can offer:
- Passionate focus on the professional and personal development of employees.
- Great development and career opportunities in a large international company.
- Dynamic workplace based on respect, where employee involvement is strongly encouraged.
- Stimulating and flexible workplace where life-navigation is an integral part of the work culture.
- Co-workers with a high level of education and competence.
- Competitive benefits package, including group insurance coverage, professional development support, and a pension plan, among others.
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.
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