Team Lead

vor 7 Monaten

Munich, Deutschland Cerner Corporation Vollzeit

**R**OLE PURPOSE**:
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

**Working Environment**:

- Hybrid or RemoteThis position offers a Hybrid or Remote working environment. Meaning if you live within a metro area of a Cerner office, you will split working time between a Cerner office and remote. If you are not within a metro area of a Cerner office, you can live and work in your current geographical location and work primarily remote. #LI-Hybrid #Remote

Back to Description

**Cerner Jobs and Careers**:
**Additional Information**:
**Working Environment**
- Hybrid or Remote**Relocation Assistance Available for this Job**:

- No**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

All employees must be legally authorized to work in the country where the position is located. Work visa sponsorship is not available for this position.

Cerner is a place where people are encouraged to innovate with confidence and focus on what is important - people’s health and the care they receive. We are transforming health care by developing tools and technologies that make it more efficient for care providers and patients to navigate the complexity of our health. From single offices to entire countries, Cerner solutions are licensed at more than 25,000 facilities in over 35 countries.
- Cerner’s policy is to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Cerner is proud to be a drug-free workplace.

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