Senior Pharmacovigilance Associate
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Job Description
Senior Pharmacovigilance Associate ensuring safety and efficacy of pharmaceutical products by managing pharmacovigilance activities. Collaborating with teams to assess safety data and regulatory compliance.
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
- 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
Requirements:
- 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%)
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
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