Pharmacovigilance

Based on many years of experience working with pharmacovigilance rules and regulations, the Pharm Assists team can help you to identify your company’s pharmacovigilance needs. We tailor our services in a way that specifically meet your requests and by consulting Pharm Assist you get a trustworthy partner knowledgeable within the broad field of pharmacovigilance.

Our broad and flexible collection of pharmacovigilance services includes but is not limited to:

  • Designing and implementing of Pharmacovigilance Systems and creation of associated documents such as SOPs, Quality Manuals, RMPs, PSURs, PSMF and Work Instructions.
  • Responsibility as EU QPPV including a 24-hour designated point of contact for the regulatory authorities
  • Duties as Local Safety Officer or pharmacovigilance specialist including for example provision of pharmacovigilance training, EudraVigilance profile maintenance, MedDRA-coding and Management, follow-up and reporting of adverse events.
  • Local and global literature surveillance
  • Signal management

At Pharm Assist, we put patient safety first, apply well-established routines and comply with applicable legislation, regulations and guidelines for Good Pharmacovigilance Practice (GVP).

In other words, we make it easy for you to comply with current laws and to fulfil the requirements and responsibilities you are obliged to as MAH or local representative.

Contact Jeanette Johansson for further information.