The Associate Manager, Drug Safety and Pharmacovigilance will report to the Director, Drug Safety and Pharmacovigilance. This individual will be responsible for processing case data, filing of safety related documents, drafting safety narratives based on company templates and meeting safety database standards. This individual will contribute to the successful completion of safety-related goals and objectives in collaboration with the clinical development team. This role requires an individual who is able to perform at a high level in a fast-paced environment. Prior safety-related expertise, with an ability to understand and comply with general pharmaceutical industry rules, regulations, company processes, SOPs and work instructions, particularly in connection with investigational drug safety and pharmacovigilance for clinical studies is essential.
Essential Duties and Responsibilities
Perform data entry and processing into ARGUS platform for single case reports
Filing of safety related documents
Assisting Safety Managers and the Director, Drug Safety and Pharmacovigilance with trial related safety objectives such as SAE reconciliation
Collaborate with clinical development functions – Medical, Clinical Operations, Data Management, Biostatistics, Regulatory and QMS
Assist with relevant projects or duties as needed
Qualifications
Bachelor's Degree in a Life Sciences discipline required
Minimum 3 years of direct experience in a drug safety/pharmacovigilance environment within the pharmaceutical industry required
Must have direct experience and working knowledge of safety platform Oracle Argus
Willingness to cooperate in case of emergency, as warranted
Maintain high personal and professional standards
Understand the complexity of the drug development space, while acting at the highest level of integrity and competence