Safety Surveillance Support Specialist

Venesco,-LLC-; Frederick (MD); On-site; USD 70,000 - 100,000; Full time

Job summary

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 include monitoring safety email inboxes, receiving and triaging adverse event reports, processing safety cases, supporting MedWatch submissions, reconciling safety databases, and preparing inspection-ready documentation.

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.

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.

Skills

Pharmacovigilance

Safety reporting

Regulatory compliance

Education

Bachelor's degree in Life Sciences, Nursing, Public Health, or related field

Tools

Argus

Job description

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.

For more information on Venesco, LLC., visit https://venesco.com.