Senior Pharmacovigilance Manager

Description:

About you

• MSc or equivalent in a life -science
• Minimum of seven years on the job experience in all the aspects of PV scientific and compliance activities
• Previously working for a small to a middle-sized pharmaceutical company

About the role

• Contribution and PV Lead for the company’s new product acquisition/ due diligence activities and/ or new market expansion.
• Lead the projects of safety data migration; apply their extensive knowledge in safety databases and case processing to ensure a compliant and accurate data transfer.
• Consult the Theramex’s stakeholders as required for the local and global PV legislative requirements; analyse the local legislation and plan for implementation of the local requirement in the global Theramex PV system.
• Preparation and negotiation of pharmacovigilance agreements; conduct PV pre-qualification of partners and service providers.
• Lead the activities for Theramex products post-authorisation safety studies (PASS).
• PV Lead the preparation of enquiries from the Regulatory Authorities as required.
• Responsible for the maintenance and improvement of the risk management system including preparation of the signal detection and risk minimization strategies.
• Responsible for the timely planning, development, execution, submission, implementation and maintenance of the Risk Management Plan(s), periodic aggregate safety reports (PSURs/PBRERs and DSURs) and ad hoc safety reports.