Senior Pharmacovigilance Lead — Hybrid, Day Shift (Makati)

ICON Clinical Research; Manila; Hybrid; PHP 600,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Annual leave entitlements

Retirement planning options

Employee assistance program

Job summary

ICON Strategic Solutions in Manila is seeking a Pharmacovigilance Associate to manage adverse event reporting and safety data analysis. You will ensure regulatory compliance and contribute to risk management across projects.

You will collaborate with clinical teams, oversee PV databases, and mentor junior staff, with a hybrid work setup and an onboarding period in Makati City. A strong PV background and experience with AE processing are required.

Qualifications

• Bachelor's degree in a relevant scientific discipline.
• At least 3 years of pharmacovigilance or drug safety experience.
• Experience in case processing of post-marketing or clinical trial cases.
• Experience using pharmacovigilance databases (ARGUS, ArisG, Veeva).
• Proven ability to manage pharmacovigilance processes, including AE reporting.

Responsibilities

• Lead collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting.
• Conduct data analysis to identify safety signals and trends.
• Prepare and submit PSURs and regulatory documents.
• Collaborate with medical and clinical teams on risk management.
• Maintain pharmacovigilance databases with accurate documentation and compliance.
• Provide training to junior team members on PV processes.
• Support audits and inspections by regulatory authorities.

Skills

Pharmacovigilance

Adverse event reporting

Data analysis

Regulatory knowledge

Communication skills

Education

Bachelor's degree in science/healthcare

Tools

ARGUS

ArisG

Veeva

Job description

ICON Strategic Solutions in Manila is seeking a Pharmacovigilance Associate to manage adverse event reporting and safety data analysis. You will ensure regulatory compliance and contribute to risk management across projects.

You will collaborate with clinical teams, oversee PV databases, and mentor junior staff, with a hybrid work setup and an onboarding period in Makati City. A strong PV background and experience with AE processing are required.