Pv Officer
vor 2 Wochen
PV Officer - Medical Review (M/F/d)-230005FC
**Applicants are required to read, write, and speak the following languages***: English
**Preferred Qualifications**
Oracle Life Sciences is a leader in cloud technology, pharmaceutical research, and consulting, trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance, throughout the therapeutic development lifecycle, including pre
- and post-drug launch activities. With more than 20 years’ experience, Oracle Life Sciences is committed to supporting clinical development and leveraging real-world evidence to deliver innovation and accelerate advancements - empowering the Life Sciences industry to help improve patient outcomes.
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Oracle Life Sciences immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.
The Senior PV Officer - Medical Review acts as Subject Matter Expert in the assigned areas (i.e. Medical Review).
This includes keeping the oversight in and proactively developing the assigned area. They keep up to date with industry standards and developments and applies the appropriate systems or processes as well as proactively implements process improvements and innovations in the assigned area.
In addition, the Senior PV Officer - Medical Review performs activities for assigned clinical and non-interventional studies as applicable.
**RESPONSIBILITIES**:
- Works across all therapeutic areas to provide expert support as needed.
- Acting as Subject Matter Expert in the assigned area
- Keep oversight in and proactively develop assigned area
- Develops timelines and assesses resource requirements for key tasks within designated area.
- Collaborates cross-functionally with other departments, especially Data Management teams.
- Development and maintenance of SOPs in the assigned area
- Performance of Medical Review activities for assigned clinical and non-interventional studies as applicable
- Represents the MR (&PV) team in cross-functional teams and task forces (related to projects, processes, and standards).
- Provides leadership regarding requirements or issues related to assigned area
- Performs work independently with mínimal supervision
- Qualifications:
- Advanced degree in a relevant scientific/clinical/regulatory field preferred.
- Master’s Degree and several years practical experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company or CRO is required.
- Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas.
- Problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external clients.
- A high degree of financial understanding and management.
- Excellent organizational and time management skills, also when working under pressure.
- Excellent command of spoken and written English (and German, preferably).
- At Oracle, we don’t just respect differences—we celebrate them. We believe that innovation starts with inclusion and to create the future we need people with diverse backgrounds, perspectives, and abilities. That’s why we’re committed to creating a workplace where all kinds of people can do their best work. It’s when everyone’s voice is heard and valued that we’re inspired to go beyond what’s been done before._
Diversity and Inclusion | Careers
Everyone’s voice is heard at Oracle. We need unique perspectives to help us innovate and grow. Learn how we’re making diversity a priority.
**Detailed Description and Job Requirements**
Responsible for conducting applied research in scientific area of focus. Investigating applicable solutions through rigorous, protracted studies and ensuring that a quality, integrated solution is delivered in a timely manner, at budget, and to our client*s satisfaction. This involves working closely with the client to understand and manage their expectations, as well as working closely with Oracle and third-party vendors to ensure delivery.
An experienced professional who is a domain and process expert with a deep understanding of research, clinical practices and solutions. Leads solution design for existing and prospective external customer engagements. Identifies areas for new solution offerings. Analyzes external customer needs and exercises judgment and business acumen in selecting methods and techniques to design non-routine and complex solutions to help ensure Oracle solution meets the customer’s objectives by combining industry best practices and program/process kn
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