At Collegium Pharmaceutical, we are building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a portfolio of meaningfully differentiated medications to treat serious medical conditions, including severe and persistent pain and ADHD.
POSITION OVERVIEW
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 oversight in related Drug Safety activities including Product Quality 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
- Interact with call center group to ensure complete and quality output and provide guidance on follow-ups, 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
- Perform reconciliation with business and licensing partners for adverse event report exchanges
- Handle product complaints related 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-related field or equivalent qualification
- Excellent communication and writing skills
- Strong knowledge of MS Office (Word, Excel, 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
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