Remote Lead Pharmacovigilance Specialist

Placements24; Willows (CA); Hybrid; USD 61,000 - 98,000; Full time

Benefits offered by this job

Competitive salary + incentives

Health insurance (medical, dental, and

Optical coverage)

Retirement savings plan

Remote work flexibility

Virtual training & conferences

Job summary

Placements24 is seeking a Lead Pharmacovigilance Specialist to oversee end-to-end PV activities in a fully remote capacity. You will manage case processing, safety reporting to regulators worldwide, signal detection, and risk management with a globally distributed PV team.

Candidates must have strong global PV knowledge (FDA/EMA/ICH), hands-on experience with safety databases (Argus, ArisG), and a track record of leading remote teams.

Qualifications

• Bachelor's degree in Pharmacy/Medicine/Life Sciences or related healthcare field.
• Master's degree or equivalent professional qualification preferred.
• Minimum 6 years in pharmacovigilance with at least 2 years in leadership.
• Knowledge of global PV regulations (FDA, EMA, ICH) and safety reporting.
• Experience with safety databases (Argus, ArisG) and case processing.
• Strong leadership, communication, and remote-management skills.

Responsibilities

• Oversee end-to-end PV processes including AE case processing and data entry.
• Ensure timely submission of safety reports to regulators worldwide.
• Lead signal detection activities and risk assessments.
• Develop and implement PV strategies, SOPs and quality systems.
• Mentor and manage a remote PV team, providing guidance and training on regulatory requirements.
• Contribute to periodic safety reviews and aggregate reports (PBRERs, DSURs).
• Act as liaison with regulatory agencies on PV matters.
• Collaborate with cross-functional teams to ensure integrated safety management.
• Manage vendor relationships for outsourced PV activities; participate in audits.

Skills

PV leadership

Regulatory knowledge

Team leadership

Safety databases

Argus ARISg

Signal detection

Risk assessment

SOP development

Remote management

AE processing

Education

Bachelor's degree in Pharmacy/Medicine/Life Sciences

Master's degree preferred

Tools

Argus

ArisG

Job description

Placements24 is seeking a Lead Pharmacovigilance Specialist to oversee end-to-end PV activities in a fully remote capacity. You will manage case processing, safety reporting to regulators worldwide, signal detection, and risk management with a globally distributed PV team.

Candidates must have strong global PV knowledge (FDA/EMA/ICH), hands-on experience with safety databases (Argus, ArisG), and a track record of leading remote teams.