Senior Associate, Drug Safety
Collegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a leading portfolio of responsible pain management and neuropsychiatry medications. This position is fully remote. 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
REQUIRED LEADERSHIP BEHAVIORS Leadership Behaviors are a core 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
- Develop
- Communicate
- Embrace Authenticity
- Guts
- Be Disruptive
- Innovate
- Evolve
- Be Tenacious
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
Collegium is an equal opportunity employer. It is the policy of Collegium, in all of its relations with its employees and applicants for employment, to base all employment-related decisions upon valid job-related factors, without regard to age, national origin, citizenship status, ancestry, race, color, religion, creed, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or expression (including transgender status), sexual orientation, military or veteran status, physical or mental disability, genetic information, or any other status protected by applicable federal, state, or local law. This policy applies to hiring, training, promotion, compensation, disciplinary measures, access to facilities and programs, and all other personnel actions and conditions of employment. By this policy, Collegium seeks to ensure that all employees have the opportunity to make their maximum contribution to Collegium and to their own career goals. This policy provides for an equal employment opportunity program that will simultaneously serve the requirements of society, the law, sound business practices and individual dignity. If you have questions or concerns about equal employment opportunities in the workplace, you are encouraged to bring these issues to the attention of the Head of Human Resources. We will not allow any form of retaliation against employees who raise issues of equal employment opportunity. To ensure our workplace is free of artificial barriers, violation of this policy may result in disciplinary action, up to and including termination. Apply tot his job Apply To this Job