Senior Pharmacovigilance Associate (Medical Review)

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

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.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

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 (https://careers.iconplc.com/reasonable-accommodations)