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hace 3 semanas
**Overview**:
- As a Senior Pharmacovigilance Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact.
**Responsibilities**:
**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.
**Qualifications**:
**You are**:
- 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 maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others
