**Job summary**:
We are looking for an experienced PV Physician with at least 3 years’ experience working as a Safety Physician in Clinical Trials within a CRO or Pharmaceutical company. The position involves working on assigned clinical trial projects and interacting with study physicians, clients, external Pharmacovigilance consultants, clinical investigators, project managers, and other relevant specialists during study set up, execution and close out. Experience working within a Safety Database environment is a requirement, and experience working within the Eudravigilance web based environment would also be an advantage.
We are searching for an experienced, ambitious and energetic person,



able to undertake challenges in the project, push forward development of the project and function well in the project team. The desired person shall be open to cross cultures communication and cooperation and shall be significantly independent in their performance.
**Key responsibilities include**:
- Writes standard operation procedures (SOPs) to cover the Pharmacovigilance processes
- Reviews Scopes of responsibilities of company projects, setting up the realization of
EastHORN pharmacovigilance responsibilities
- Writes company Safety Management Plans and Safety Reporting Plans
- Reviews other company project plans
- Ensures compliance with necessary reporting timelines
- Reviews SAE cases to determine missing/required information
- Follows up on missing/required information
- Performs medical review of Serious Adverse Events, evaluates causality and expectedness
- Performs medical coding of Adverse Event verbatim terms into MedDRA
- Reviews MedDRA medical coding of terms
- Writes SAE narratives and analysis of similar events
- Performs triage of SAE cases to determine if they meet the expedited safety reporting
requirements
- Prepares expedited and periodic safety reports when required




- Manages proper storage of data on adverse events
- Performs / coordinates safety report submissions
**Other responsibilities include**:
- Opportunity to act as Study Physician/Medical Monitor on studies
- Performs other routine and non-routine pharmacovigilance/drug safety activities as required
- Assists client at registration with Eudravigilance, when needed
- Acts as Responsible Person for Eudravigilance on behalf of client, when needed
- Performs Eudravigilance SUSAR reporting and enters IMP information into Eudravigilance medicinal product dictionary
- Follows all new safety reporting requirements
- Works with external PhV Consultants, as needed
- Provides Post Marketing Pharmacovigilance activities
- Writes company Pharmacovigilance Plans
**Minimum Requirements**:
- At least 3 years experience as Safety Physician in Clinical trials in CRO or Pharmaceutical Company
- Medical/Dental Degree obtained at a recognized University




- At least 2 years experience managing patients in Hospital or General/Dental Practice
- Experience in neurology can be beneficial
**Required Qualifications, Experience, Competencies**
- Knowledge of PhV processes, drug development process, ICH/GCP guidelines and local regulatory requirements
- Experience in setting-up/conducting clinical trials and evaluation of adverse events
- Excellent organizational and time management skills
- Skills to handle multiple priorities and to work with deadlines and under pressure
- Excellent presentation, written and oral communication skills
- Excellent client facing interaction skills
- Fluent in written and verbal English
- Computer competency
- EU Based
- Home or Office Based
**Benefits**:




- Working with experienced and very professional and supportive team
- Possibility to grow within the Company
- Competitive remuneration
- Flexible working time
- Eligibility to the Company Bonus scheme