Safety Surveillance Support Specialist

Summary

Safety Surveillance Support Specialist

Venesco LLC is seeking a Safety Surveillance Support Specialist to support pharmacovigilance and clinical safety activities by processing safety reports, monitoring adverse event information, maintaining safety databases, and supporting regulatory reporting requirements.

Duties and Responsibilities

• Monitor safety email inboxes and reporting systems.
• Receive and triage adverse event reports.
• Process safety cases and follow-up information.
• Support MedWatch and regulatory reporting submissions.
• Reconcile clinical and safety databases.
• Maintain safety documentation and records.
• Support DSMB preparation and logistics.
• Assist with safety trend analysis.
• Support annual safety reports and study closeout activities.
• Ensure documentation is inspection ready.

Minimum Qualifications

• Bachelor's degree in Life Sciences, Nursing, Public Health, or related field.
• Minimum 3 years of pharmacovigilance or drug safety experience.
• Familiarity with Argus or similar safety systems.
• Knowledge of FDA and ICH safety reporting requirements.

Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.

Job Description

Safety Surveillance Support Specialist

Venesco LLC is seeking a Safety Surveillance Support Specialist to support pharmacovigilance and clinical safety activities by processing safety reports, monitoring adverse event information, maintaining safety databases, and supporting regulatory reporting requirements.

Duties and Responsibilities

• Monitor safety email inboxes and reporting systems.
• Receive and triage adverse event reports.
• Process safety cases and follow-up information.
• Support MedWatch and regulatory reporting submissions.
• Reconcile clinical and safety databases.
• Maintain safety documentation and records.
• Support DSMB preparation and logistics.
• Assist with safety trend analysis.
• Support annual safety reports and study closeout activities.
• Ensure documentation is inspection ready.

Minimum Qualifications

• Bachelor's degree in Life Sciences, Nursing, Public Health, or related field.
• Minimum 3 years of pharmacovigilance or drug safety experience.
• Familiarity with Argus or similar safety systems.
• Knowledge of FDA and ICH safety reporting requirements.

Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.