An excellent opportunity has arisen for a PV Manager to join a Pharmaceutical client based in South London on a full time basis. Within this role you will manage the PV & MI team to maintain patient safety and provide expertise and knowledge to ensure the client maintains the relevant processes and procedures to remain compliant with current Pharmacovigilance legislation. Specifically, you will also ensure the department effectively collaborates with other company PV departments, and managing the external PV service provider.
Demonstrate strong and dynamic leadership and management of PV & MI team (currently 2 full-time employees).
Drive a culture of continuous improvement.
Ensures maximum oversight, maintenance and responsibility of the internal PV system, set-up with different partners and the internal PV & MI department for compliance assurance
Liaise with PV service providers in order to safeguard the business interests of the company.
Ensure pharmacovigilance (PV) activities performed at the company are completed in an efficient and effective manner, and in compliance with company procedures and relevant legislation and regulation.
Ensure that team provides high quality Medical Information (MI) service to external third parties regarding products marketed and manufactured by the company in line with the code of conduct.
Provide expert advice and guidance to internal colleagues on PV and product safety matters.
Comply with relevant legal and compliance requirements, regulatory and ethical standards and the company’s SOPs.
Experience and Qualifications:
Science degree or equivalent business experience
Extensive knowledge of the relevant UK and EU legislation for PV (experience in MENA region is advantageous).
Strong interpersonal skills at all levels, including people management, leadership, interactions with stakeholders in terms of both written and verbal communication skills.
Strong knowledge of RMPs.
Good experience with Signal Detection activities, PSUR Vendors and compliance management PVAs.
Experience in leading a successful team
Some experience working in Medical Information desirable
Attention to detail with the ability to multitask
Ability to critically appraise scientific/clinical data
Good IT skills