SDEA Specialist

Proclinical is currently seeking a SDEA Specialist for a multinational specialty pharmaceutical and medical device company that develops, manufactures and markets a broad range of prescription and non-prescription pharmaceutical products that make a meaningful difference in patients’ lives throughout more than 100 countries. This jobs location can be based in, but is not specific to, Poland. 

Job Responsibilities:

• Reviews and manages Third Party agreements, and maintains ongoing list of Third Party Agreements.
• Maintains exchange of safety data with vendor, including the reconciliation of cases.
• Perform initial intake of incoming adverse events for post marketed products if applicable.
• Follows up on adverse events when necessary.
• Monitoring of websites of local Health Authorities for adverse events.
• Acknowledges receipt of adverse event information from applicable partners (e.g. Customer Service Centre) and reconciles data exchange.
• Maintains continuous knowledge and expertise in requirements for safety reporting.
• Assists in global safety submissions to Health Authorities.
• Reviews and manages Third Party agreements, and maintains ongoing list of Third Party Agreements.
• Maintains exchange of safety data with vendor, including the reconciliation of cases.
• Maintains continuous knowledge and expertise in requirements for safety reporting.
• SDEA, Third Party Agreements responsibility
• Acting as contact point for business partners, other departments, third party provider(s), authorities and other partners regarding SDEAs
• Reports to Head of Global ICSR Group, Pharmacovigilance

Skills and Requirements:

• Life Science Degree
• Experiences in Pharmacovigilance
• In-depth knowledge of medical terminology, with experience using MedDRA
• Strong organizational skills, detail-oriented, ability to adapt in a fast paced and changing environment
• Proven oral and written communication skills in German and English
• Ability to work under pressure to meet tight deadlines
• Ability to work independently and self-motivated
• Experience in Pharmaceutical Industries, multinational CROs and Research institutes
• Experiences in databases (ARGUS, ARISg)
• Experiences in MS-Word, Excel, Power Point, Access, Outlook
• Experience in customer oriented working.
• Adequate theoretical and practical knowledge for the performance of pharmacovigilance activities and processing of contracts

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on +44 207 4400 636 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.