Our client is a fast growing highly profitable multinational biotechnology company with an exciting pipeline of drug compounds at an advanced stage in research. With a highly experienced and successful executive management team this company has a newly created vacancy for an experienced Senior Manager, Global Safety and Pharmacovigilance. With flexibility to work from home this position will be located in Dublin.
The Sr. Manager is an experienced professional who provides pharmacovigilance expertise for deliverables and activities associated with signal detection, safety and benefit-risk evaluations for company products, management of potential safety issues, and evaluation of databases for safety signals.
•Manages the daily PV operations functions, including the processes for collection, monitoring, processing, and distribution of adverse event reports for investigational and marketed products.
•Prepares, contributes, and assists as subject matter expert with writing and maintaining standard operating procedures and guidelines for case processing operations.
•Generates internal and external report outputs from the safety database.
•Completes data entry of incoming reports from clinical trials and post marketing sources in accordance with applicable regulations, company SOP’s and applicable licensing agreements with high level of accuracy, accountability, and minimal supervision.
•Completes triage of incoming reports for initial assessment of seriousness, expectedness, causality, and reportability for reports from clinical trials and post marking sources in accordance with local work instructions, US FDA regulations, and international guidelines and regulations with high level of accuracy, and accountability.
•Actively participates in vendor management and oversight.
•Contributes to supporting regulatory submissions, reviews case report form data for safety issues, and reconciles clinical trial data.
•Performs active follow-up via verbal or written contact with healthcare professionals and consumers when needed
•Provides internal and external safety training.
•Contribute to the development of the Risk Management Plan and/or Risk Evaluation and Mitigation Strategies.
- Completes initial assessment of safety signals and prioritizes safety signals for full evaluation.
- Coordinates and author sections of aggregate reports (PSUR, IND annual, NDA annual etc.).
- Reviews literature for designated products.
Bachelor's degree plus 3 years of experience with case management, safety database administration, technology applications, change control processes, and/or systems validation.
In depth understanding of medical terminology
In depth knowledge of US Code of Federal Regulations, EMA, and ICH clinical and post marketing safety regulations and reporting process, guidelines for adverse events and validation requirements for safety databases
In depth knowledge of Good Clinical Practices (GCP).
• At least 5 years of biotech/pharmaceutical industry experience, including at least 3 years of
experience in pharmacovigilance operations.
• 3-5 years relevant clinical safety, regulatory, or risk management experience strongly preferred
• Experience with database administration, database coordination, and data entry.
• Working knowledge of MedDRA coding and upgrade experience
• Develop queries and produce reports/outputs from Oracle AERS database
• Experience with regulatory inspections and audits is strongly desired.
• Demonstrated experience with development, authorship and review of aggregate reports
(PSUR, ASR, IND annual, NDA annual etc.), Risk Management Plans, and Risk Evaluation and
Mitigation Strategies is highly desirable.
Minimal travel may be required.
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