This opportunity will allow you to lead and develop all pharmacovigilance activities for clinical development & commericalised products.
Develop the PV team and organisational capabilities responsible for managing the outsourced PV activities, ensuring service quality and cost-effectiveness. Balance internal resources and outsourcing in alignment with the company needs and business model. Organize and monitor the processing and medical review of Individual Case Safety Reports (ICRs) for compounds in clinical development and post-marketing. Discuss the ICSRs with the Project Medical Directors and ensure the timely reporting to the Authorities / clinical sites / partners.
Evaluate the overall safety profile of compounds: in collaboration with the different company experts and/or partners/vendors, evaluate and update the risk-benefit profile of internal compounds (post-marketing and in development), write periodic safety reports (Development Safety Update Reports (DSURs), Periodic Safety Update reports (PSURs). Manage the signal detection activities and risk management plan for the different compounds. Perform signal evaluation & validation. Manage PV activities according to the existing Safety Data Exchange Agreements (SDEAs). Update the SDEAs if necessary. Secure the maintenance and the accuracy of the PV database Report regularly pharmacovigilance activities to the VP of the Clinical Research & Development Department and to the Project/Clinical Study Teams. Maintain up to date expertise in pharmacovigilance and develop the expertise of the PV team.
MD, 5 to 10 years years experience in Pharmaceutical industry
Previous management experience Track record managing service providers such as CROs. Experienced in writing safety reports, risk management plans and other safety documents. Able to work closely with Clinical Development teams. Experienced in setting up PV processes and building organization capabilities. Excellent knowledge of pharmacovigilance and regulatory procedures (Swiss, Europe and USA). Good communication and negotiation skills. Ability to work and influence within a matrix organization. Hands-on readiness and good attention to detail.
You will need to lead by example and be hands-on.
This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply without delay as it is likely that recruitment will close prematurely. Please direct all questions (if necessary) to "Chris" at cswain (at) barringtonjames (dot) com alongside a copy of your CV.