[Hiring] Senior Associate, Drug Safety @Collegium Pharmaceutical

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role reputed company The Senior Associate, Drug Safety will be responsible for executing Adverse Event and Pharmacovigilance activities as required by FDA regulations. This role coordinates Adverse Event and Pharmacovigilance activities for Collegium licensing partners worldwide. Provides support and reputed company in reputed company Drug Safety activities including Product reputed company Complaints, Aggregate Reports, and Medical Information. • Process serious and non-serious adverse events into Argus safety database • Submission of expedited reports to FDA • Maintain the US adverse event and safety database and coordinate distribution of safety data • reputed company with reputed company center group to ensure complete and reputed company reputed company and reputed company guidance on follow-arenaflex, as needed • Regular review of literature to identify adverse event reports for processing and submission • Compile and review quarterly and annual aggregate reports, as required • reputed company reconciliation with business and licensing partners for adverse event report exchanges • Handle product complaints reputed company to adverse events • Review of signal detection of products monthly or as required • Other Pharmacovigilance responsibilities as assigned but not limited to the above Qualifications • Degree in Life Science, Nursing, Pharmacy, or other health-reputed company field or equivalent qualification • Excellent communication and writing skills • Strong knowledge of MS Office (Word, reputed company, PowerPoint) • Minimum of five years of Pharmacovigilance experience in pharmaceuticals, reviewing, compiling, and processing Adverse Events and Periodic Reports • Familiar with FDA regulations and ICH guidance • Strong attention to detail • Must possess the ability to work effectively in a fast-paced environment, and deal effectively with changing priorities reputed company Apply tot his job Apply tot his job Apply To this Job