PharmaAccess Pharmacovigilance Service
PharmaAccess provides well regarded Pharmacovigilance functions to ensure you are compliant with the legislation and therefore protecting your product assets. Our clinical knowledge and commercial understanding delivers a compliant, ethical and balanced approach to risk management in the pharmaceutical industry. Pharmaceutical, biotechnology, medical device and cosmetic companies can rely on the proven expertise of PharmaAccess.
Get in touch with us today to find out more!
Get in touch with us today to find out more!
What our Pharmacovigilance Team cover
For medicines, our experienced team efficiently assess and process adverse events and reactions from clinical trials and post-marketing. We operate a validated safety database and our experts will ensure you comply with the requirements for expedited and periodic reporting or, reviewing literature and safety signal detection. We provide qualified persons to be your Local Person for Pharmacovigilance, with the QPPV maintaining oversight for the whole PV operation.
We have significant experience in writing standard operating procedures (SOPs), thus safeguarding your patients’ safety. We are expert in safety data exchange agreements (SDEAs) and the auditing of third parties in line with a risk assessment plan, constructively improving processes and driving compliance in partner companies. We also provide PV training to ensure that employees comply with the regulatory requirements. Our team are experienced in handling and reporting serious undesirable effects and safety assessments.