Description
ICON is seeking a Senior Pharmacovigilance Associate to join their team in Sofia, Bulgaria. 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.
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.
- Set-up, maintain and close-out studies as a PV Lead; writing Safety Management Plans, performing PV budget reviews and attending client meetings.
- 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.
Requirements:
- 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.
Rewards & Benefits:
- 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