Senior Associate, Drug Safety

This position is fully remote. POSITION 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. RESPONSIBILITIES • 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-reputed company, 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 REQUIRED LEADERSHIP BEHAVIORS Leadership Behaviors are a reputed company set of behaviors that vary based on Level in the organization. We have categorized these under Head, Heart, and Guts. • Head • Know our Business • Think Critically • Decide • Execute • Heart • Collaborate • reputed company • Communicate • reputed company Authenticity • Guts • Be Disruptive • reputed company • reputed company • Be Tenacious 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 Apply tot his job Apply To this Job