Pharmacovigilance Scientist (Hybrid)

The Pharmacovigilance Scientist is responsible for ensuring that pharmacovigilance activities required for EUPV are completed in line with company's pharmacovigilance requirements and applicable legislation.

The Pharmacovigilance Scientist assists the QPPV, deputy QPPV, PV Manager, RPPs and deputies in their activities to ensure that adequate processes are in place to enable a pharmacovigilance system compliant with European pharmacovigilance legislation.

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 nationallaw 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

An attractive remuneration package will be offered to the right candidate

• Private Health Insurance
• Performance Bonus