Drug Safety Team Leader
hace 2 semanas
At Insud Pharma, we are seeking a highly skilled and experienced Drug Safety Team Leader to join our team. As a key member of our Pharmacovigilance department, you will be responsible for ensuring legal and regulatory compliance with pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP).
Key Responsibilities:- Coordinate the activities related to the Pharmacovigilance System, Quality Management System, and safety from clinical trials.
- Act as Deputy Qualified Person Responsible for Pharmacovigilance (Deputy QPPV) in the absence of the QPPV.
- Collaborate in the maintenance of the Pharmacovigilance System Master File.
- Ensure readiness for audits and inspections, and collaborate with QA PV staff in the management of deviations/CAPA plan.
- Collaborate in the maintenance of the Quality Management System of Chemo Organization, and give support in the elaboration and update of Global Standard Operating Procedures (SOPs).
- Active collaboration on pharmacovigilance activities related to clinical investigation, including reviewing and management of safety in clinical protocols (AE/SAE/SUSAR), organization of DSUR, reconciliations with CRO, and reviewing CSR.
- Collaborate in the Signal Committee and signal detection processes.
- Ensure proper preparation, review, and submission of safety reports (periodic safety update reports (PSUR), risk management plans (RMP), and renewals).
- Supervise the implementation of additional risk minimization measures (aRMM).
- Collaborate in the coordination of response to the Spanish and foreign country health authorities.
- Supervise the implementation of the training programs and ensure proper training of the employees.
- Supervise the elaboration, management, follow-up, and implementation of PV contracts and agreements with third parties, and collaborate in the service providers contracts.
- Keep PV files safe, accurate, updated, and complete, in compliance with internal standards and applicable regulations.
- Collaboration on vigilance activities related to medical device incidents (management of cases, evaluation, submission, archive).
- Ensure adequate interface and communication with other departments performing activities impacting Chemo PV system, such as Regulatory Affairs, Medical, Legal, Marketing, and Commercial departments.
- University Degree in Health Sciences (Pharmacy, Medicine, Odontology).
- In case of Biology, Biotechnology, etc., it shall be necessary a Health Science orientation.
- Fluent English and Spanish, knowledge of other languages will be an asset.
- At least 1 year in similar positions (Team Leader, Local contact person for PV, Team manager, etc.).
- At least 5 years of experience in a Pharmacovigilance department in a medium-large pharmaceutical company, preferably demonstrating responsibilities for global PV tasks.
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