Job Employment Available at IQVIA

About this Job

PURPOSE

Serve as the LQPPV for clients who need the services for their product(s).

RESPONSIBILITIES

• Observe the guidelines outlined in the IQVIATM Lifecycle Safety Regulatory Intelligence Database (RID) as the LQPPV.

• Being accessible 24/7 to take calls from the neighborhood Competent Authority as necessary. serve as the point of contact for pharmacovigilance reviews. During statutory inspections, speak directly with the inspectors from the Competent Authority.

• Guaranteeing company continuity and having backup/deputy coverage in place in the event of an absence

• Promote pharmacovigilance at the national level and make sure that client affiliate organizations are aware of pertinent functions (such as regulatory affairs, clinical, and QA).

• In order to evaluate a pharmaceutical product's risks and benefits, Competent Authorities may ask for information on sales, prescriptions, and post-authorization safety studies, among other things. You must respond to these requests completely and quickly.

• Confirms that, prior to the start of the contract, the Competent Authority received notification of his or her identity and contact information. The MAH may choose to let the Agency know or may delegate to the LQPPV or project lead.

• Keep abreast of any modifications to local regulatory standards, and confirm that the risk management strategies are followed as well as the relevant regulatory systems and safety measures.

• Set up and maintain project resources, such as project files, forms, templates, databases, and processes. Establish and maintain a complete understanding of each project's budget and scope of work (SOW).

• Work in a cooperative team setting with the project team both locally and remotely; set an example; and help managers allocate resources to projects. Within the QPPV job, independence will be expected.

• Actively seek out problems and offer remedies. All requests should be handled quickly and effectively.

• Report on project metrics, SOW modifications, and client requests and concerns on a regular basis to the project manager; take part in management project review meetings; prompt communication of project issues with the project team and department management;

• Send the EU QPPV/designee frequent monthly updates, and finish all necessary regulatory reports.

• In terms of PV roles and responsibilities, collaborating and communicating with the European Union Qualified Person for Pharmacovigilance (EU QPPV) of the MAH.

• Report any new signs of safety concerns to the MAH and/or EU QPPV (where relevant).

• Continues to be aware of the sources and avenues via which country-level safety information is communicated.

• Makes ensuring that systems and procedures are in place to guarantee the timely collection and reporting of safety data.

• Establishes procedures and frameworks to guarantee the creation and prompt submission of periodic reports.

• Keeps abreast of regularly reviewed local literary journals and makes sure procedures are in place to find and report pertinent safety information obtained from local journals.

• Ensures knowledge of the changing safety profiles of the nation's legally prescribed medications.

• Ensures that local risk-reduction initiatives are known about and are under control.

• Participate in the gathering, translation, recording, and follow-up of Individual Case Safety Reports (ICSRs) and/or other safety information not specifically related to ICSRs that is pertinent to the pharmaceutical product(s) under consideration for the project.

• May aid in the submission of pharmacovigilance reports to the appropriate authorities, such as Individual Case Safety Reports, Periodic Safety Update Reports, Risk Management Plans, and Risk Minimization Materials.

As required, aid in the creation of corrective and preventative measures.

• Support pharmacovigilance inspections and routine audits.

• Provide recommendations to corrective/preventative action plans related to inspections, audits, or deviations and support local compliance initiatives as required.

• If local laws require it, review and approve risk management plans as well as regular safety update reports.

• Makes ensuring local risk-reduction measures are put into practice.

• As required, review and contribute to regional pharmacovigilance contracts and agreements.

• Manage the master files for the local pharmacovigilance system as necessary.

• Make careful to include pharmacovigilance in clinical study protocols as needed.

• Ad-hoc tasks should be completed when directed.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED

• Comprehensive understanding of relevant international, regional, and local regulatory standards as well as International Conference on Harmonization (ICH) recommendations

• Comprehensive understanding of the legal system in the country where LQPPV services are provided.

• Thorough familiarity with the pertinent Standard Operating Procedures (SOPs).

• During statutory inspections, speak directly with the competent authorities and submit questions by regulatory authority inspectors.

• Possess strong communication abilities both in writing and speaking

• Excellent analytical and problem-solving skills while reading safety reports and other materials and conducting inspections.

• Show that you can work both individually and in teams and that you have a good mindset.

• Telephone etiquette that works

• Demonstrate confidence, professionalism, and credibility when engaging with customers and other parties Strong organizational and project management skills

• Possesses the capacity to establish and sustain good working connections with coworkers, managers, customers, and other stakeholders.

• Keep track of the product's safety profile and any elements that might have an impact on the benefit/risk ratio.

• Display an awareness of quality management systems and compliance

MINIMUM SKILLS AND EXPERIENCE NEEDED

• An equivalent mix of education, training, and experience; a bachelor's degree in a life science, medicine, pharmacy, or nursing, or an educational equivalent, and two years of relevant clinical experience, including management of post-marketing safety and clinical trial safety; A citizen of the nation where LQPPV services are offered who is fluent in the local language and has a strong grasp of English.

FITNESS REQUIREMENTS

• Frequent usage of the phone and in-person interaction necessitates accurate speech perception.

•  Frequent use of the keyboard necessitates repetitive finger activity.

• Regularly spending a lot of time sitting down

• Contactable by phone 24/7 for inquiries to the Competent Authority (where mandated by law)

• Possibly entails some travel

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