Description: Job Title: Qualified Person Location: Europe Schedule: Permanent
TalentSource Life Sciences is searching for an experienced Qualified Person in Europe to work with one of our partner Clients - an Asian pharmaceutical company - who are expanding their novel products in Oncology and Rheumatology in Europe.
The successful candidate will be working on studies dedicated to one client. As a client-facing role, we are looking for confident candidates with strong site management skills and the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager. Responsibilities:
- Oversee and support the activities of pharmacovigilance contact persons at the European level
- Ensure the EU QPPV services are delivered in accordance with the Sponsor's policies, procedures and contractual agreements
- Contribute to scientific safety services, such as safety writing including RMP and PSUR, signal detection and/or literature surveillance
- Maintenance of global PV database/support system
- Oversee and support audit/Inspections
- Plan and implement PV Corrective Action & Preventative Actions
- Input into development of client PV systems
- Promotion of good practices within the Pharmacovigilance team, including through engagement in process improvement activities and delivery of training
Experience, Skills, Knowledge
- BSc in Life Sciences, nursing degree or equivalent. MSc or higher preferred.
- Certified/licenced as a Qualified Person in accordance with EU Directive 2001/83/EC
- Extensive proven experience as a Qualified Person, managing or implementing Pharmacovigilance systems
- Previous Quality Assurance experience
- Work experience within EMA or PRAC
Why choose TalentSource Life Sciences/CROMSOURCE?
- Strong knowledge of pharmacovigilance and drug safety
- Previous experience with Medical Writing
- Signal detection
- Pharmacovigilance audit experience
- Extensive knowledge of GPvP rules and regulations
- Assertive personality
- Flexible and resilient
- Team player
- Excellent communication skills, both written and verbal
- Fluency in English
CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge
CROMSOURCE comes from the merger of MSOURCE and CROM in 2011 and we are great at recruitment and staffing services! We're proud to partner with the industry's leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide, securing great global talent. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
For the client client-facing positions, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on studies for just one client.
How can we help you on your next career move? Learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor. Keywords:
Qualified Person, Pharmacovigilance, QP, PV, QPPV, GPvP, Contract, Temporary, Contract Research Organisation, Permanent, Employee, Freelance, Contractor, Temporary, Pharma
Skills: Qualified Person, Pharmacovigilance Location: Europe Share:
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