Descripción de la oferta
- Sin Experiencia
- Sin estudios
- Salario a negociar
This position is responsible for establishing and maintaining the Market Authorisation Holder/Applicant’s (MAH/MAA, referred to as the Client) Pharmacovigilance System, overseeing the global safety profile of the client’s products approved in Europe or in application, and acting as a single point of contact for the Regulatory Authorities on a full time, 24 hours / 7 days a week basis.
Specific Job Duties:
• Establishes and maintains/manages the Client’s PV system to ensure full compliance with all legal and regulatory requirements in the EU.
• Has an oversight of the Pharmacovigilance System Master File (PSMF) and its maintenance.
• Has an overview of the safety profiles and any emerging safety concerns in relation to the medicinal products for which the Client holds or has applied for authorizations in EU.
• Has an awareness of any conditions or obligations adopted as part of the marketing authorization and other commitments to safety or the safe use of the Client’s medicinal products.
• Acts as the main point of contact with the relevant Competent Authorities and is available to be contacted by them 24/7.
• Has an oversight of all aspects of the Client’s PV system. Can delegate tasks but maintains ultimate responsibility for PV activities including: Individual Case Safety Reports (ICSRs), Standard Operating Procedures (SOPs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMP), including review and approval, Post Authorization Safety Study (PASS) protocols, including review and approval, Risk Minimisation Strategies, effectiveness of follow-up measures, post-marketing commitments, the safety database, e-transmission and of findings / observations from Regulatory Authorities Inspections, QA/Client audits of PV activities and other safety-related audits.
• Ensures expedited and periodic submission of all PV-related documents in accordance with legal requirements and GVP.
• MD, PharmD, post graduate degree in a science or health-related field, pharmacy or nursing. If not medically qualified, shall have access to a designated medically qualified person.
• At least 8 years of experience in pharmacovigilance.
• Strong experience in pharmacovigilance in Pharmaceutical Companies, biotech or CRO.
• Deep knowledge of other aspects of product development and post marketing product management (e.g., regulatory, risk management, benefit risk, epidemiology, medical affairs).
• Excellent knowledge of pharmacovigilance regulations and legislation.
• Strong leadership, analytical, organizational skills.
• Strong written and verbal communication skills.
• Strong presentation skills.
• Strong interpersonal skills.
• Must be able to speak fluent English.
• Official full time residence and operates in the EU.
• Ability to travel from time to time to UBC locations, clients, and professional/scientific meetings.