Qualified Person for Pharmacovigilance(Spain & selected EU locations)

Parexel International Corporation

Spain - Any Region - Home Based

Qualified Person for Pharmacovigilance required for a 5 - 8 month contract.

Job Purpose:

The QPPV or deputy QPPV shall serve in this role for Parexel clients. This individual shall be at the marketing authorisation holder’s (MAH) disposal permanently and continuously, be responsible for the establishment and maintenance of the MAH pharmacovigilance (PV) system and therefore shall have sufficient authority to influence the performance of the quality system and the PV activities and to promote, maintain and improve compliance with legal requirements. This includes having access to the PV System Master File (PSMF) and be in a position of authority to ensure and to verify that the information contained in the PSMF is an accurate and up-to-date reflection of the PV system under the QPPV’s responsibility. The QPPV shall reside and operate in the European Economic Area (EEA) or United Kingdom (UK) depending on the role covered and legislation requirements . The QPPV or deputy QPPV will act in accordance with applicable regulatory requirements in addition to providing Safety Consulting Services to Parexel clients, as and when required. In accordance with strategic imperatives, the QPPV or deputy QPPV will support the development of the QPPV & Safety Consulting Services business at Parexel. This may include working with Business Development (BD), Solutions Consultants, Account Management, Marketing, Business Operations and Operational teams in addition to supporting new business opportunities through involvement in proposal development and bid / client meetings. Accountability Supporting Activities Act as EUQPPV or Deputy QPPV for multiple projects as required • Have a detailed overview of medicinal product safety profiles and any emerging safety concerns including any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products • Review and approve risk minimization measures • Review and approve the content of risk management plans • Review, sign-off of protocols and complete oversight of post-authorization safety studies and their results conducted or pursuant to a risk management plan • Oversight for conduct of PV and submission of all PV related documents in accordance with the legal requirements and regulations • Review and oversee the PV system quality, including the correctness and completeness, of PV data submitted to the competent authorities • Review and oversee all responses to any request from the competent authorities for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product • Provide any other information relevant to the benefit-risk evaluation to the competent authorities • Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals) • Acting as a single PV contact point for the competent authorities on a 24-hour, 365 days per year basis and as a contact point for PV inspections • Support PV Inspections Support Safety Consulting Assignments • Provide Safety Consulting services for clients as and when required • Support internal project teams as Subject Matter Expert as required Support the growth of QPPV & Safety Consulting Services • Engage with commercial teams and marketing to support and improve the selling of Safety Consulting services, including SME input to proposals, and participation in client capabilities/sales meetings and bid pursuit meetings as and when needed • Represent the business at relevant conferences to support business growth • Maintain positive client relationships to drive repeat businessQualificationsSkills:

• Solid PV knowledge and experience to influence the PV system

• Comprehensive knowledge of clinical, scientific, and medical aspects of drug/device safety and principles of pharmacovigilance

• Excellent knowledge of ICH, CIOMS, and safety/pharmacovigilance regulations in all major regions

• Excellent interpersonal, verbal and written communication skills

• Strong analytical skills and ability to identify and address issues proactively in a timely manner

• Demonstrated leadership skills

• Ability to manage multiple and varied tasks and prioritize workload with attention to detail

• Highly effective communicator at all levels with both clients and internally. Must be open and direct with strong oral and written communication skills

• Experience in Pharmacovigilance as per legislation requirements

• Expert knowledge of applicable pharmacovigilance regulations

Knowledge and Experience:

• Demonstrated experience in managing or implementing PV systems, including quality assurance experience

• Documented experience in all aspects of PV in order to fulfill the responsibilities of the QPPV.

• Extensive knowledge of global pharmacovigilance regulations and GVP and GCP guidelines

• Experience in pharmacovigilance safety risk management including clinical trials, post-market pharmacovigilance, safety case processing, safety reporting, and safety systems

Education:

Medical qualification in acknowledged Medical School with sufficient experience in clinical medicine or Life Science Graduate with relevant PV experience. Proficient in English and local language/s if required by local/regional applicable legislation.


2022-05-14 00:05:20


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