Senior Pharmacovigilance Associate (Medical Review)

ICON Strategic Solutions; Metro Manila; Hybrid; PHP 450,000 - 900,000; Full time

Benefits offered by this job

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme (

Life assurance

Flexible country-specific optional ben

Job summary

ICON Strategic Solutions offers a sponsor-dedicated pharmacovigilance role focused on drug safety across a global framework. You will own PV deliverables, manage AE reporting, and collaborate with cross-functional teams in a hybrid setup in Makati, with an initial 3-month onsite training and a 8am–5pm day shift.

The role requires 3+ years in PV, strong regulatory knowledge, and experience with PV databases (ARGUS/ArisG/Veeva). You will mentor juniors and support audits and inspections globally.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• At least 3 years of experience in pharmacovigilance or drug safety with experience in case processing.
• Experience using pharmacovigilance databases (ARGUS, ArisG, Veeva, etc).
• Proven ability to manage the pharmacovigilance process including AE reporting and signal detection.
• Strong analytical and critical thinking skills for interpreting complex data.
• Excellent communication and interpersonal skills for cross-functional collaboration.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Willingness to work in a hybrid setup (2-3x RTO in Makati City) with 3 months onsite training.
• Willingness to work in Day Shift (8am-5pm).

Responsibilities

• Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.
• Conducting data analysis and interpretation of safety data, identifying trends and potential safety signals that require investigation.
• Preparing and submitting PSURs and other regulatory documents, ensuring compliance with international regulations.
• Collaborating with medical and clinical teams to assess clinical relevance of reported adverse events and contribute to risk management.
• Overseeing maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data standards.
• Providing training and mentorship to junior team members on PV processes and regulatory requirements.
• Engaging in audits and inspections by regulatory authorities, ensuring readiness and compliance with PV requirements.

Skills

Pharmacovigilance

Case processing

Data analysis

Regulatory knowledge

Education

Bachelor's degree in relevant science

Tools

ARGUS

ArisG

Veeva

Job description

JR145059 Pharmacovigilance Associate

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Senior Pharmacovigilance Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and oversee pharmacovigilance activities.

What You Will Do

You will take ownership of pharmacovigilance and drug safety deliverables, applying your expertise to complex challenges.

Key Responsibilities Include

• Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.
• Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation.
• Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations.
• Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities.
• Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.
• Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements and best practices.
• Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.

Your Profile

You will have a strong foundation in pharmacovigilance and drug safety, with the experience to work independently and guide others.

Required Qualifications And Experience

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• At least 3 years of experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards. Must have experience in case processing of either post-marketing or clinical trial cases.
• Must have experience using pharmacovigilance databases (ARGUS, ArisG, Veeva, etc)
• Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection.
• Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations.
• Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Willingness to work in a hybrid setup (2-3x RTO in Makati City); Subject to 3 months of onsite training upon onboarding.
• Willingness to work in Day Shift (8am-5pm)

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Benefits

Medical insurance