We are currently looking to recruit Pharmacovigilance Scientist to join an established pharmaceutical company in Malta.
Responsibilities:
Support QPPV, Deputy QPPV and PV manager in project management for general system review.
Support the QPPV, Deputy QPPV and PV manager in their activities to ensure compliance of the Pharmacovigilance system with European legislation
Support the development of relevant processes, practices, and standard operating procedures, with reference to European laws and guidance (including the provision of review support for specific EU SOPs and related documents).
Coordination of company training covering EU territory in line with PSMF established processes and GVP legislation.
Coordination of Authorities searches and monitoring of safety communication from the Authorities and product restrictions.
Management of Monthly Compliance monitoring as defined and established in the PSMF of MAH.
Coordination of cooperation with all EU affiliates and designated RPPs.
Product list management in liaison with GPVD/GRAD teams.
Safety Variation Management.
Liaise with the QA/RA Manager to ensure that the provisions of the licence are observed, operations do not compromise the quality of medicines and ensure full and prompt cooperation with product licence holders in the event of recalls.
Ensure that any additional requirements imposed on certain products by national law are adhered to.
Support the QA/RA Manager, as required, in the investigation of deviations and customer complaints, and support execution of corrective and preventative actions and related documents to ensure compliance is achieved and maintained and any other activity relevant to GDP.
Requirements:
Bachelor's Degree in Life Sciences, Pharmacy or related fields
Previous experience in a similar role is a big plus
Must demonstrate strong analytical and problem-solving skills
Excellent communication in English
Job Reference: QB059