Collegium Pharmaceutical, Inc. · 18 hours ago
Senior Associate, Drug Safety
United States
Full-time
Remote
Senior Level
$90K/yr - $104K/yr
5+ years expCollegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. The Senior Associate, Drug Safety will be responsible for executing Adverse Event and Pharmacovigilance activities as required by FDA regulations and coordinating these activities for Collegium's licensing partners worldwide.
BiotechnologyLife ScienceMedicalTherapeutics
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
Qualification
Required
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
Company
Collegium Pharmaceutical, Inc.
Collegium Pharmaceutical is building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions.
201-500 employees
H1B Sponsorship
Collegium Pharmaceutical, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (1)
2022 (1)
2021 (3)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.29BKey Investors
TPG BiotechNational Institute on Drug Abuse (NIDA)Frazier Healthcare Partners
2025-12-30Post Ipo Debt· $980M
2023-02-07Post Ipo Debt· $203.2M
2015-05-07IPO
Leadership Team
Vikram Karnani
President and CEO
Colleen Tupper
EVP & Chief Financial Officer
Recent News
2026-01-09
MarketScreener
2025-12-31
2025-12-30
Company data provided by crunchbase