Senior Safety Associate

Mersana Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Operations
  • Post Date: 02/14/2021
  • Website: mersana.com
  • Company Address: 840 Memorial Drive, Cambridge, MA, 02139

About Mersana Therapeutics

Mersana is rewriting the rules for immunoconjugate therapies by leveraging our Fleximer platform to create precisely targeted and highly tailored drugs that radically improve patients’ lives.

Job Description

In this role, you will have an opportunity to be at the front lines and responsible for triaging and managing the review and submission of SAE reports.  You will frequently liaise with the Medical Monitors for review and finalization of safety reports. As you compile and review safety data for safety review meetings, posters, etc., you will form close partnerships with colleagues in Pharmacovigilance/Clinical Development Operations, Regulatory Affairs, and Data Clinical Sciences.  If you have not worked in oncology in the past, this is a great opportunity to apply your drug safety and medical knowledge and learn about the exciting ADC therapies. 

This role will report to the Associate Director, Safety and Pharmacovigilance

 
How do you know if you’re the right fit?

Your previous experience will have been in a safety/pharmacovigilance role in the pharmaceutical/biotech industry with a clinical/medical background. You are proactive, are skilled in prioritizing, and enjoy knowing your efforts will make a significant impact on the oncology studies. You will be comfortable reading patient charts, are familiar with medical terminology and abbreviations, and are able to work in a fast-paced environment in a small, rapidly growing company.  You’ll fit right in if you:

  • Have a demonstrated ability to be thorough and detailed oriented,
  • Possess strong QC skills when reviewing SAE cases, CIOMS reports, and safety data
  • Are aware of and able to proactively manage reporting timelines,
  • Can produce quality work under tight timelines,
  • Have strong organizational and follow through skills with the ability to work with minimal supervision
  • Are proficient in reviewing clinical data
  • Thrive in a fast-paced, growing organization 

The other stuff

This is typically a role best suited for someone with a BS or RN who possesses at least 3-4 years of previous drug safety/pharmacovigilance experience, preferably in oncology.

 In addition, the successful candidate will possess:

  • Working knowledge and understanding of FDA/GCP/ICH regulatory requirements
  • Strong interpersonal and communication skills as well as the ability to collaborate cross functionally
  • Ability to review and understand safety information and data listings
  • Knowledge of international safety reporting guidelines

Position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation and paid holidays.

Successful candidate must be authorized to work in the United States.

Mersana Therapeutics, Inc. is an equal opportunity employer.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.