Senior Specialist Clinical Safety

Job title:

Senior Specialist Clinical Safety

Company

Cencora

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!Job DetailsWe have an exciting opportunity for a Senior Clinical Safety Specialist to join our team in Norway!The role will include:

• Data entry and QC of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature; reporting of ICSRs to the competent authorities
• Support in the generation, processing, documenting, and tracking of follow-up requests
• Screening and documentation of scientific literature regarding safety relevant publications
• Assist in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports), risk management plans and signal detection reports
• Interact with customers as needed (e.g. meetings, client visits, day to day case processing, etc.)
• PSMF maintenance
• Contribute to/review QA documents such as Working Instructions, SOPs, Working Procedures, templates, project metafiles, etc. for PharmaLex pharmacovigilance projects
• Prepare for and participate in internal and external audits/inspections
• Training new colleagues in relevant tasks
• The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required.

.Skills

• Team-oriented approach
• Organizational skills, ability to multi-task. Ability to assimilate and analyse information rapidly.
• High sense of responsibility and self-motivation
• Highly service-oriented
• Flexibility and adaptability to adjust rapidly to new, unknown, challenging situations.
• Fluent written and spoken English skills.
• Excellent written and verbal communication skills.

Experience/Background

• Successful completion of a Bachelor’s degree in medical, natural sciences or pharmacy-related field or Degree in Medicine
• At least 1 year of relevant professional experience in the field of Pharmacovigilance.
• Knowledge of safety databases (Argus, Safety Easy are preferred)
• Experience in case management activities
• Previous experience in pre-authorisation area.

What Cencora offers​Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.Full timeAffiliated Companies Affiliated Companies: PharmaLex Norway ASEqual Employment OpportunityCencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Expected salary

Location

Oslo

Job date

Sat, 03 May 2025 02:12:33 GMT

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