Description
ICON is seeking a Senior Pharmacovigilance Associate to manage and oversee pharmacovigilance activities, ensuring the safety and efficacy of pharmaceutical products.
The successful candidate will take ownership of pharmacovigilance and drug safety deliverables, applying their 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.
- Working in the safety database to perform data entry, narrative writing, and query management, as well as quality control of other processors' cases.
- Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities.
- Leading studies as the PV Lead, acting as the primary contact for the client and Project Manager, writing SMPs, and attending Kick-off meetings and client calls.
- 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.
The ideal candidate will have:
- A Bachelor's degree in a relevant scientific discipline or healthcare-related field.
- 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.
- Willingness to travel as required (approximately 15%).
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development, which may include:
- Competitive base salary and performance-related incentives.
- Health and wellbeing programmes, including medical, dental, and vision coverage where applicable.
- Retirement and pension plans.
- Life assurance and disability coverage.
- Employee assistance programmes and wellbeing resources.
- Learning and development opportunities through structured training and career pathways.