PV Manager - Immuno-Oncology

Due to continuous growth one of our clients are looking for a Pharmacovigilance Manager to lead and ensure the safety of projects. This is an excellent opportunity in Germany to build close relations with international medical and clinical teams

Job Responsibilities

• Being responsible for all Sponsor activities related to day-to-day processing of incoming serious adverse event reports and, where applicable, expedited reporting to regulatory authorities, partners.
• Contribute to aggregate safety data review, signal detection and risk evaluation for the molecules under clinical development.
• Responsible for the assembling and review of the Development Safety Update Report.
• Being the main point of contact for our PV service provider.
• Monitors the quality and performance of the Global Safety Database to ensure consistent, effective and efficient oversight of core pharmacovigilance process.
• Providing safety related support to clinical and medical teams.
• Creates and maintains Pharmacovigilance Agreements with business partners. Liaises with internal legal/contract representatives as required. Budget and invoice management for global PV related tasks.
• Ensuring compliance with PV related responsibilities defined in contracts, PV agreements, cooperation documents and other applicable documents.
• Ensuring that all Pharmacovigilance activities are conducted in accordance with internal SOP's, Good Clinical Practice guidelines and regulatory requirements.
• Advises and supports compliance with pharmacovigilance regulations, guidelines and standards (including audit/inspection readiness) to optimize departmental quality, standards, and training.
• Conducts reviews and gap analysis on new Pharmacovigilance regulations, and guidance documents; produces recommended plans for implementation within the company and is responsible for creating and delivering training.

Skills and Requirements

• Master's Degree in Life Sciences (medical/biomedical sciences, pharmaceutical sciences) with 3-5 years in clinical safety/clinical pharmacovigilance and preferably 1-3 years in PVG compliance and quality.
• Demonstrated ability to apply principles, concepts and industry best practices governing pharmacovigilance in assigned projects and company deliverables.
• In depth knowledge of global safety reporting activities, regulations, ICH/GXP guidelines, and pharmaceutical industry compliance practices (incl. also MedDRA) and be able to provide guidance regarding regulatory requirements internally to Patient Safety and externally to other functions.
• Experience in development of standards and training strategies within pharmaceutical industry and experience of negotiation of safety agreements with business partners.
• Highly organized, outcome oriented, problem solving, understanding of research methods and basic data analysis, excellent teamwork, and strong communication skills; including CAPA management.
• Strong attention to detail and persistence in following tasks through to completion.
• Excellent verbal and written communication skills in English.
• Very good knowledge of standard software (Word, Excel, Outlook, Power Point, CTMS/EDC systems) is a must
• General understanding of R&D processes especially in Biotech companies

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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