Pharmacovigilance Specialist Onsite in San Clemente

Pharmacovigilance Specialist - Onsite in San Clemente, CA

The Pharmacovigilance specialist will report to the Senior Manager, Pharmacovigilance. This position is based in San Clemente, California. The individual is responsible for Post Market and Clinical trial PV Case Processing. The role requires high performance in a fast-paced environment, with prior safety-related expertise, and the ability to understand and comply with pharmaceutical industry rules, regulations, and company processes.

How will you make an impact?

The Pharmacovigilance specialist will process adverse event information for spontaneous, solicited, literature, and phase IV study cases. The role involves performing drug safety activities to ensure compliance with pharmaceutical and medical device regulations.

What will you do?

1. Perform tasks and duties in compliance with SOPs, policies, and procedures.
2. Review ICSRs in safety database for completeness, accuracy, and regulatory reportability.
3. File safety-related documents and ICSRs. Review adverse event data from product complaints, inquiries, and literature, assessing for regulatory reporting requirements.
4. Identify information to be queried and follow up with PV vendors/medical safety until resolved.
5. Collaborate with cross-functional teams including Medical, Clinical Operations, Data Management, Biostatistics, and Regulatory.
6. Assist in safety and risk management activities and other safety projects as assigned.
7. Ensure compliance with safety reporting requirements of the FDA and other agencies.
8. Perform other duties as necessary.

How will you get here?

1. Bachelor's Degree in a Life Sciences discipline required; graduate degree and/or post-doctoral training preferred.
2. 3 to 5 years of experience in drug safety/pharmacovigilance within the pharmaceutical industry required.
3. Experience with safety database systems and medical terminology required.
4. Understanding of post-marketing safety requirements for device/combination products.
5. Knowledge of FDA, ICH, and GCP regulations.
6. Proven integrity, accuracy, and attention to detail.
7. Strong technical and analytical skills.
8. Good organizational skills with project prioritization abilities.
9. Excellent written and oral communication skills.