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