Senior Pharmacovigilance Associate Post-Marketing (FSP - Sponsor Dedicated)

ICON; São Paulo; Presencial; BRL 120.000 - 150.000; Tempo integral

Resumo da oferta

A leading clinical research organization in São Paulo is seeking a Senior Pharmacovigilance Associate to ensure the safety and efficacy of pharmaceutical products. The role involves managing pharmacovigilance activities, analyzing safety data, and submitting regulatory reports. Ideal candidates should possess a Bachelor's degree in life sciences and extensive pharmacovigilance experience. The position offers a competitive salary and a comprehensive benefits package, emphasizing work-life balance and personal well-being.

Serviços

Annual leave entitlements

Health insurance offerings

Retirement planning

Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualificações

• Extensive experience in pharmacovigilance or drug safety.
• Strong understanding of relevant regulations and industry standards.
• Ability to manage adverse event reporting and signal detection.
• Excellent analytical skills to interpret complex data.
• Proficient communication skills to collaborate across teams.

Responsabilidades

• Lead collection and reporting of adverse event reports.
• Conduct data analysis and identify safety trends.
• Prepare and submit safety update reports complying with regulations.
• Collaborate with medical teams for assessing adverse events.
• Maintain integrity of pharmacovigilance databases and documentation.
• Provide training to junior team members on best practices.
• Prepare for audits and regulatory inspections.
• Stay updated on regulatory guidelines to enhance processes.

Conhecimentos

Pharmacovigilance process management

Data analysis

Regulatory compliance

Communication skills

Critical thinking

Team collaboration

Microsoft Office Suite proficiency

Confidentiality maintenance

Formação académica

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Ferramentas

Pharmacovigilance databases

Data management systems

Descrição da oferta de emprego

Senior Pharmacovigilance Associate Post-Marketing (FSP - Sponsor Dedicated)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Senior Pharmacovigilance Associate to join our diverse and dynamic team. As a Senior Pharmacovigilance Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities. You will collaborate with cross-functional teams to ensure compliance with regulatory requirements and to maintain the highest standards of patient safety.

What You Will Be Doing:

• 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.
• Staying informed on evolving regulatory guidelines and industry best practices to continually enhance the pharmacovigilance processes within the organization.

Your Profile:

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field. An advanced degree is preferred.
• Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards.
• 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.
• Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite.
• Ability to work independently and manage multiple priorities in a fast‑paced environment.
• Commitment to maintaining confidentiality and handling sensitive patient information with discretion.

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 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply.