- 经验
- 1–3 yrs
- 薪水
- —
- 职位空缺
- 1
- 发布
- 2小时前
- Work mode
- 在家办公
- 学历
- PharmD
- Eligibility
- Candidates with 1 to 3 years of pharmacovigilance or drug safety experience are encouraged to apply; a PharmD is preferred.
- Resume
- Required to apply
职位描述
Role overview
An innovative biotech company is looking for a Pharmacovigilance Associate to support routine drug safety operations on a contract basis. This position is suited to someone with early-stage experience in pharmacovigilance who wants to deepen their knowledge of case handling, safety systems, and regulatory compliance in a dynamic environment.
Assignment details
- Contract duration: 6 months, with the possibility of an extension or conversion to a full-time role.
- Work schedule: 40 hours per week.
- Work mode: Remote.
Key responsibilities
- Handle adverse event case processing and participate in quality review checks.
- Support safety data management activities and reconciliation tasks.
- Work with internal teams and external collaborators to keep safety operations running smoothly.
- Help with inspection readiness efforts and ongoing process enhancements.
Required experience and knowledge
- 1 to 3 years of experience in pharmacovigilance or drug safety.
- Strong preference for candidates with a PharmD.
- Practical exposure to ICSR case processing and quality control review.
- Experience using safety databases and managing the full case lifecycle, from intake through submission or distribution.
- Ability to support case follow-up and maintain data quality throughout the workflow.
- Working understanding of global pharmacovigilance regulations and guidelines, including ICH E2A, E2B(R3), and E2D, as well as FDA and EMA reporting concepts.
- Familiarity with pharmacovigilance SOPs.
- Knowledge of medical coding practices and safety data quality standards.
Additional information
This opportunity is intended for a candidate who can contribute effectively in a fast-moving biotech setting and grow within drug safety operations.
Application note
The hiring team invites interested candidates to get in touch directly for more details.