Direct message the job poster from Skilled Recruitment Solutions GmbH
Senior Recruitment Consultant - Skilled Recruitment Solutions GmbH
On behalf of our partner, a pharmaceutical sponsor located in Basel, we are looking for a Drug Safety Case Manager to support their team. Candidates who wish to facilitate the transition from the CRO are most welcome to apply as well.
Responsibilities:
* End-to-end processing of adverse event (AE) case reports, including case triage, data entry, AE coding, narrative writing, quality control, and timely submission of expedited AE reports to health authorities.
* Prioritization of cases in accordance with relevant Standard Operating Procedures (SOPs) to ensure compliance with regulatory submission timelines.
* Identification of missing information and initiation of follow-up requests in collaboration with the Drug Safety Physician.
* Daily monitoring of workflows and task lists to ensure proper prioritization and processing of cases.
* Execution or oversight of reconciliation activities to ensure data consistency.
Requirements:
* University degree in life sciences or an equivalent qualification in a health-related field.
* Minimum of 5 years of experience in pharmacovigilance/drug safety.
* Strong knowledge of medical terminology and a solid understanding of disease processes.
* Proficiency in medical coding systems and drug dictionaries.
* In-depth knowledge of EMA and FDA safety reporting requirements.
* Excellent organizational, problem-solving, and interpersonal skills, with the ability to work efficiently under pressure and meet tight deadlines.
* Fluency in English, both written and spoken.
Seniority level
* Associate
Employment type
* Full-time
Job function
* Science and Research
Industries
* Pharmaceutical Manufacturing
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