GDP Responsible Person and Local Pharmacovigilance Contact, Poland
Job Description
Ensuring that the distribution of medicinal products, is carried out in accordance with the law, Good Distribution Practice. Maintaining a pharmaceutical quality system. Acting as the person responsible for pharmacovigilance in Poland. Ongoing contact with the Main Pharmaceutical Inspectorate and URPL.
Job requirements
Education & Experience
· Degree in pharmacy
· Experience of working in the distribution of medicines (wholesale trade) as a benefit
· Experience in contacts with regulators like URPL or GIF as benefit
· Experience with registration of medicinal products as benefit
· Experience in setting up quality systems as benefit
· Fluent English, native in polish
Business & Industry Knowledge
· Deep understanding of the healthcare industry
· Knowledge of pharmaceutical distribution law
· Knowledge of the SAP environment as a benefit
Communication & Collaboration
· Excellent communication and presentation skills.
· Ability to work cross-functionally with Sales, Marketing, Logistic, Quality, Pharmacovigilance and Regulatory team
Project & Time Management
· Proven ability to manage multiple projects and meet tight deadlines.
· Ability to work under time pressure
· Independence in the performance of your duties
Independence level/ reports to
Collaborating with specialists across Europe. / Division Manager CEE North
Tasks
1. Reporting to ZSMOPL in accordance with the provisions of the pharmaceutical law.
2. To send the list of qualified carriers to the Main Pharmaceutical Office ( GIF ) in accordance with the announcement on their website.
3. Checking regularly on the website of the Official Journal of the Ministry of Health the list of medicinal products at risk of access in the Republic of Poland.
4. Qualifying recipients entitled to purchase our medicinal products in accordance with Art. 36g of the Pharmaceutical Law and the pharmaceutical quality system.
5. Auditing contractors including the carrier in accordance with the Regulation on Good Distribution Practice and the pharmaceutical quality system.
8. Filing of CoCs (certificates of compliance) for exempted medicinal products.
9. Coordinating complaints in accordance with the Pharmaceutical Law and company policy (eQMS).
10. Providing pharmacovigilance in the Republic of Poland.
11. Ensuring that transport is carried out in accordance with the quality contract and Good Distribution Practice (GDP)
12. Coordinate post-registration changes in URPL regarding distributed medicines
