Required QPPV, Israel
The QPPV is a senior position within the pharmacovigilance team, responsible for ensuring that we comply with all regulatory requirements related to the safety of its medicinal products. The QPPV is the primary point of contact for the Israeli MoH and our global partners and ensures that we meet our legal obligations regarding the monitoring, assessment, and reporting of adverse drug reactions
Responsibilities
Communicating with the Ministry of Health regarding pharmacovigilance activities, ensuring compliance with local regulations. This includes timely submission of safety reports and responding to inquiries and requests
Overseeing the internal PV system, ensuring its effectiveness and continuous improvement, including processes, tools, and personnel
Managing the safety agreements with our global partners and external suppliers, if applicable
leading PV audits conducted by our global partners and inspections conducted by the Ministry of Health
Communicating with our global partners, including participation in periodic meetings, as required
Monitoring the compliance of our employees with internal procedures, including corrective actions as needed
Collaborating with internal departments such as Regulatory Affairs and Medical Affairs to address pharmacovigilance issues
Ensuring coordination with the Quality Assurance team to ensure pharmacovigilance processes align with company standards
Additional tasks as defined by the manager.
Requirements: Required education and experience
A degree in Pharmacy or Medicine, with a valid Israeli license, and with a minimum of two years of experience in their profession
Proven experience in Pharmacovigilance, with at least 4 years in a relevant role
In-depth knowledge of pharmacovigilance regulations, including local and international standards
Fluency in English and Hebrew, both written and spoken
Proficiency in Microsoft office (Word, Power Point, Outlook and Excel)
Required qualification:
Excellent communication skills, both written and verbal
Attention to detail and the ability to handle complex safety data accurately
Ability to work independently and as part of a cross-functional team
Ability to manage multiple tasks simultaneously while maintaining high-quality deliverable
Ability to work under pressure and meet deadlines
Critical thinking and problem-solving skills to identify potential safety issues
High level of agility, with the ability to quickly adjust to changing priorities and emerging challenges in a fast-paced environment.
This position is open to all candidates.