Pharmacovigilance Professional
4 weeks ago
Quanta Consultancy Services Ltd is seeking a highly skilled Senior Pharmacovigilance Manager to join their team in the UK. This role offers a unique opportunity to work with a global biopharmaceutical company, providing high-quality medicines for rare diseases worldwide.
About the Company:
- We are a leading consultancy services provider, dedicated to delivering exceptional solutions in pharmacovigilance and regulatory affairs.
- Our client is a renowned biopharmaceutical company, committed to advancing treatments for life-threatening diseases.
About the Role:
Key Responsibilities:- The successful candidate will be responsible for managing case-processing activities, ensuring accurate detection of safety data, and maintaining compliance with international regulations.
- This includes proper management of worldwide/national literature research, data reconciliation, and Aggregate Reports (PSURs, PAERs, RMPs, AdCOs).
- The ideal candidate will have experience in drafting the Safety Study Plan (SSP), Investigator's brochure (IB), and Development Safety Update Reports (DSUR).
- Demonstrated competence in obtaining, analysing, disseminating, and reporting safety information in compliance with global regulations.
Requirements:
- Masters degree in life sciences field
- 8+ years of experience in drug safety and pharmacovigilance in the pharmaceutical industry
- Experience with use of safety databases, preferably Veeva Vault
- Knowledge of UK, FDA, EU, and international adverse event reporting regulations per ICH guidelines
Benefits:
- A competitive salary of approximately £80,000 - £100,000 per annum
- Ongoing professional development opportunities
- A dynamic and supportive work environment
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