Mylene Paumier at CK Clinical is recruiting for a Medical Information Manager to join a global pharmaceutical company at their site based in Germany on a permanent basis.
Responsibilities:
As Medical Information Manager you will be responsible for:
- Management and accountable for correctness, actuality, plausibility, consistency and safety of all informative texts (spc, leaflet, publicity)
- Medical-pharmaceutical consulting hotline
- Medical and pharmaceutical correspondence with patients, pharmacists, doctors
- Correspondence with agencies wrt leaflet and spc
- Contact point for any medical and pharmaceutical queries from internally or externally, in close cooperation with QA
You will also be responsible for the management and accountability of PV and medical information related SOPs. Official local “Stufenplanbeauftragter” according to German law. You will be responsible for:
- Managing all local aspects of PV for DEA
- Cooperating with EU PV team wrt Psurs, audits
- Collect quality information concerning adverse drug reactions (ADRs) with Company products
- Follow-up local cases for further clarification with the reporter and HCPs and completeness when necessary (according to the SOP)
- Forward the ADR/AE information to the Pharmacovigilance Department Region II as per the applicable SOP
- Complete the management and reporting of processed AE/ADR cases received locally or from the Region II Pharmacovigilance Department to the local CA if required in accordance with local regulations
- Ensure the receipt of product quality complaints and communication to the Medical Information team
- Ensure timely submission of the PSURs distributed to them and maintain a submission log
- Ensure local literature monitoring
- Upon the receipt of the updated Reference Safety Information inform Regulatory Departments of variation requirements to the local SPCs
- Ensure and monitor Pharmacovigilance compliance with local regulations
- Notify the EEA QPPV regarding any new or additional national Pharmacovigilance requirements for the countries of responsibility
Qualifications and skills:
As Medical Information Manager, you will have the following qualifications, skills and experience:
- Excellent and broad pharmaceutical and pharmacological knowledge
- Excellent understanding and knowledge of relevant local end EU legislation, guidelines and best practice related to pharmacovigilance and medical information
- Practical work experience in a public or hospital pharmacy
- Good understanding of technical aspects (regulatory timelines and requirements, QA, IP, manufacturing aspects etc)
- Excellent German and fluent English
How to apply:
For more information or to apply for this Medical Information Manager position, please contact Mylene Paumier on 01438 743047 or email mpaumier@ckclinical.co.uk. Please quote reference CL24562 in all correspondence.
