Pharmacovigilance Director / QPPV

The Head of Pharmacovigilance has an overall responsibility for pharmacovigilance at Movetis. He/she is also the QPPV for the EEA. The Head of Pharmacovigilance reports to the Chief Development Officer of the company.

Principal responsibilties

QP:

• Fulfil the role of QPPV in accordance with the applicable EU regulations. The EEA QPPV is accountable for the performance and maintenance of the Pharmacovigilance System and is responsible for PV compliance
• Keep oversight of the global pharmacovigilance systems, enabling compliance with world-wide pharmacovigilance obligations
• Accountable for the appropriate performance by delegates engaged to carry out any part of the pharmacovigilance and compliance responsibilities. Such delegates can be employees, consultants, vendors, development and/or commercial partners
• Responsible for the contracting, hiring, review and technical approval of contracts with delegates of the PV system , including with CROs, SDEAs with partners
• Responsible for acting as single point of contact to competent authorities, and communicating new and emerging safety concerns to the competent authorities in a time frame appropriate to the benefit risk assessment
• Maintains a detailed knowledge of EU and US legislation on pharmacovigilance and assessing its impact on the business and product development programmes. • Organizes, chairs, and minutes the monthly QP meeting to exchange information on ongoing safety issues, regulatory safety issues, signals undergoing evaluation , case compliance metrics, and other aspects of the PV system
• Maintains documentation necessary for QP office: mailbox, website, folders etc to ensure appropriate availability and communication with all members of PV system
• Develops the Pharmacovigilance Quality Audit schedule, receives all audit reports and develops/ implements CAPS on relevant findings
• Monitors performance and compliance via monthly meetings, audits/ inspections

Head PV : responsible for the continuous oversight of safety of Movetis products

• Responsible for medical review of individual safety case reports, case series review, safety surveillance, evaluation of safety signals
• Responsible for research activities (literature, clinical and postmarketing database searches) to retrieve safety data, and analysis of data
• Writes and reviews reports and key documents, such as safety assessments, PSURs, RMPs and ad hoc responses to regulatory inquiries on product safety issues
• Provides safety expertise to clinical development teams by: input into safety sections of protocol, oversight of safety during trial conduct, summary of safety data in CSRs, regulatory submissions, and other documents.

The Head of Pharmacovigilance creates and manages an in-house and external pharmacovigilance team. He/she will be responsible for the growth and adaptation of the pharmacovigilance department to meet the needs of the company. He/she will develop and manage the pharmacovigilance-related budgets as appropriate.

The Head of Pharmacovigilance will implement policies, systems and a culture to ensure ongoing compliance of pharmacovigilance requirements. He/she will be responsible to ensure the development and execution of safety education and training of employees and vendors.

The Head of Pharmacovigilance is a core member of the Labeling Committee, and contributes expertise to the development of appropriate sections of the label. He/she will be responsible for the maintenance of Section 4.8 Adverse reactions, ensuring it accurately reflects the current safety profile of Movetis products.

The Head of Pharmacovigilance is an ad-hoc member of the Development Team, the R&D Board and other teams, as appropriate.

Job Requirements

Education

• A Medical Degree - Meeting the requirements to be appointed as QPPV in the EU

Experience

• A minimum of 7 years experience in pharmacovigilance within the pharmaceutical industry, including at least five years experience in a senior pharmacovigilance role
• Experience with GI products is a plus
• Expert knowledge of pharmaceutical regulations, standards, current industry practices and strong experience with interpretation and application
• Solid and proven pharmacovigilance experience, both for products in development and marketed products.

Other qualifications, skills and abilities

• Hands-on mentality and flexibility to thrive in an entrepreneurial and fast-growing environment
• Excellent written and oral communication, presentation and facilitation skills
• Strong negotiation, risk management and problem solving skills
• Demonstrated ability to manage and build relationships with colleagues and regulatory authorities
• Demonstrated success in leading and coaching others, meeting established schedules, and resolving technical and operational challenges in a matrix environment
• Ability to identify risks, and make decisions independently, and escalate issues when necessary
• Confident, pro-active, team spirit and the ability to work under time pressure
• Fluent in English, both oral and written
• Working knowledge of MS Office

Compensation

MOVETIS offers a competitive package which includes a competitive salary and a bonus.