Country Safety Head
LOA: 6 months
The Country Safety Head (CSH) is the primary Pharmacovigilance (PV) point of contact for the local territory. The CSH is responsible for the end-to-end operation, management and oversight of local PV tasks in compliance with all applicable local regulations, guidance and global business requirements. The CSH is a key strategic partner for the local business and provides valued consult and collaboration to all affiliate stakeholders and functions to support local objectives. The CSH also contributes to the Global and Regional PV strategy as required.
Essential Skills and Qualifications Required:
- Proficiency in English if not native language and local language
- In-depth knowledge of Global, Regional and local PV regulations and requirements.
- Excellent written and verbal communication skills including.
- Well-developed technical writing skills with the ability to produce clear, concise documentation and communications. Good presentation and analytical skills.
- Excellent Project Management skills.
- Good proficiency with common software such as Microsoft Word, Excel, PowerPoint, Outlook.
- Must work effectively/collaboratively in a fast-paced and matrixed environment.
- Individual has effective managerial skills (as applicable to job role and scope), is a self-starter, ability to adapt - to work independently or as part of a team, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritize.
- Strong decision-making skills required.
- Must demonstrate initiative to effectively identify and communicate issues.
- Individual should be able to demonstrate innovative thinking.
Education and Experience Requirements for Job:
- Knowledge of Good PV Practices
- Direct experience in GxP compliant quality systems preferred
- Experience with interacting with third parties (e.g PV operations vendors) required
- Experience with Adverse Events Intake systems
- Experience in writing procedures, training materials and effectively delivering training to a diverse audience
- Experience (e.g. interviewee, control room, document request) of Audits and Regulatory Inspections preferred.
Education: Minimum of bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences required.
Experience: 3-5 years in drug safety/pharmacovigilance in pharmaceutical industry setting or the equivalent for Manager Level above.
Fluent English & German required. French is a bonus.