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Camurus is a Swedish research-based pharmaceutical company committed to developing and commercializing innovative and long-acting medicines. We are strengthening our global Patient Safety team at the headquarters in Lund by recruiting Patient Safety Managers. You will work with committed colleagues with both post-marketing and development projects. Camurus is a rapidly growing and innovative company, and you will have a strong impact on the activities in the development of the Safety database. You will report to the Director of Patient Safety.
Job Responsibility:
Ensure a compliant Pharmacovigilance System for safety surveillance for Camurus products
Support digital surveillance by using data driven methods and approaches
Conduct and drive the digitalisation, automatization, and surveillance activities of safety systems and databases and its life cycle management in accordance with applicable legislation
Drive and lead internal cross-functional teams (Safety, IT Quality, etc.) for safety database projects and activities
Ensure alignment of supplier qualifications, audits, and ongoing performance monitoring activities with the overall strategic activity plan
Ensure adherence to company policies, industry standards, and applicable regulations (FDA, EMA, ICH)
Establish, develop, and maintain strong relationships with key and strategic collaboration with several departments internally to ensure continuous improvement and efficiency, quality, of the safety database and compliance of the activities
Perform review and quality control of ICSRs/SAE and ensure timely submission and exchange of these
Develop the quality system in the area of expertise, as per GVP requirement
Support the QPPV to enable the QPPV to maintain oversight of the Safety database
Requirements:
Experience within Drug- or Patient Safety/Pharmacovigilance from the pharmaceutical/medical device industry
Background as a pharmacist, nurse or an education within pharmacology or pharmaceutical science
Experience with ICSR/SAE processing, signal detection, aggregate report compilation, and clinical trials
Experience with case processing in safety databases
Experience with database administration of one or more Pharmacovigilance databases
Experience with cross-functional IT projects
Experience with quality processes regarding Change Control and Good Documentation Practice
Knowledge of GVP, regulatory compliance, and quality
Experience with safety database administration
Self-driven, attentive to details, with a proven ability to deliver results in a fast-paced organization
Ownership and a pragmatic mindset
Collaborative and solution oriented
Strong business acumen together with excellent communication and stakeholder management skills
What we offer:
International work environment and corporate culture