Team Lead

Team Lead - Pharmacovigilance (M/F/d)-230005FD

**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 Team Leader Pharmacovigilance leads and manages all activities within the Pharmacovigilance group and thereby ensures that work is performed in accordance with internal SOPs and working practices, ICH and industry guidelines, 21 CFR part 11, and other regulations. They review and approve Pharmacovigilance documents and project specifications and provides / supervises Pharmacovigilance budgets and timelines.
Furthermore, the Team Leader Pharmacovigilance participates in recruitment and performance review of personnel. They are responsible to develop assigned people in the PV team. In collaboration with the Quality Management they establish and maintain Pharmacovigilance relevant standard operation procedures (SOPs), job descriptions and training programs.
They anticipate in new business development activities and performs other tasks assigned by the line manager.
In addition to the Team Leader responsibilities, the Team Leader Pharmacovigilance also prepares study-specific documents (e.g. Safety Management Plans), processes and tracks of adverse events and other safety relevant information from clinical trials and non-interventional studies (NIS) in consideration of applicable timelines including writing of narratives, coding and reconciliation. They may also be responsible for the creation of annual safety reports, e.g. Development Safety Update Reports.

**RESPONSIBILITIES**:

- Pharmacovigilance resource planning
- Provision / supervision of budgets, timelines and Pharmacovigilance activities
- Participation in recruitment process in collaboration with line manager and Human Resources
- Training and mentoring of Pharmacovigilance personnel
- Development and maintenance of Pharmacovigilance job descriptions, SOPs and work instructions
- Ensuring work is performed in accordance with internal SOPs and working practices, ICH and industry guidelines, 21 CFR part 11, and other regulations
- Perform PV tasks
- May participate in cross-functional process improvement initiatives
- Qualifications:
- Extensive Pharmacovigilance experience within a CRO environment
- Proven project leadership and people management skills
- Excellent analytical skills
- Established expertise within the healthcare and pharmaceutical sector
- Strong client management and business development skills
- Ownership of key deliverables with major clients
- Ability to work closely with Clinical Team to develop and communicate the organization’s point of view
- 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._

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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**

This entry level manager position is responsible for a small unit within a given practice focused on a specific industry, product/service line, technology center, specialty area or region. Responsible for managing the three main pillars of a practice: people management, portfolio/delivery management and sales enablement.

As a first line management role, responsible for directing and reviewing the team’s work to achieve operational or research-centric targets or objectives with measurable contribution towards the achievement of immediate and short-term results for the team and department. Establish and communicate team goals that support and advance team