- Experience
- 3–5 yrs
- Salary
- —
- Openings
- 1
- Posted
- 3 weeks ago
- Work mode
- In office
- Education
- RN, BSN, RPh, or PharmD
- Eligibility
- Independent candidates who are USC or GC only. W2 engagement.
- Resume
- Required to apply
Where you'll work
Job description
Role overview
Talent Groups is looking for a Drug Safety Specialist to support safety case processing for both marketed and investigational products. This position is based in Waltham, MA and is structured as an onsite contract role.
Key responsibilities
The selected professional will handle drug safety case processing from start to finish, contribute to clinical safety work, and coordinate with internal partners as well as CROs. The role also involves maintaining compliance with FDA, ICH, and GCP requirements while supporting regulatory safety reporting activities.
Requirements
- Clinical credentials such as RN, BSN, RPh, or PharmD.
- Three to five years of experience in pharmacovigilance or drug safety.
- Practical experience with adverse event and serious adverse event case processing, along with safety surveillance.
- Working knowledge of FDA, ICH, GCP, and regulatory safety reporting expectations.
- Hands-on experience with safety databases such as Argus, ARISg, Clintrace, or similar platforms.
- Strong clinical judgment, communication skills, and the ability to stay organized.
- Oncology pharmacovigilance exposure is considered an advantage.
Additional information
This is a W2 requirement and only independent candidates who are USC or GC are being considered.