As a Drug Safety Associate, you will be responsible for assessing the safety of pharmaceutical drugs from literature articles. You will determine whether medications cause adverse reactions in patients and report findings to regulatory bodies and health authorities. This role involves close collaboration with safety teams within Sitero and with external Contract Research Organizations (CROs) and partners.
Essential Duties and Responsibilities:
- Facilitate effective cooperation with clients in literature monitoring.
- Ensure literature screening activities comply with global regulations and company policies.
- Assist in developing literature search strategies.
- Perform literature screening to identify potential ICSRs and other safety-related information.
- Maintain records and track all literature abstracts screened and full articles reviewed.
- Forward ICSRs to PV Associates for data entry into the global drug safety database.
- Perform peer review QC of abstracts.
- Access and download MLM search and MLM ICSR results from EV on a daily basis.
- Track MLM search results, MLM ICSRs list downloads, and exported ICSRs.
- Keep the EMA MLM Literature Screening Tracker updated.
- Assist in regulatory inspection preparedness and participate in PV inspections or audits.
Education and Experience Required:
- Minimum 1 year of relevant experience in Literature Screening or Literature case processing.
- Degree in Life Science/Pharma or equivalent.
Preferred Skills:
- 2+ years of experience in drug safety or clinical research.
- Awareness of safety databases and scientific coding browsers like MedDRA, WHO, etc.
- In-depth knowledge of drug safety/pharmacovigilance regulations.
- Strong organizational, documentation, and interpersonal skills.
- Good working knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines.
- Experience with safety data collection and interpretation from various sources.
- Ability to build relationships and collaborate across disciplines.
- Excellent verbal, written, and presentation skills.
- Innovative, collaborative, and proactive.
Compensation & Benefits:
Sitero offers a competitive compensation package, including a competitive salary, variable pay, paid time off, healthcare, and retirement benefits.
Commitments:
- Standard hours: 40 hours per week, Monday – Friday.
- Willingness to work in shifts as needed.