Director, Local Pharmacovigilance

Role Summary 

The Director, Local Pharmacovigilance (LPV) is part of the Medical Affairs Group, reporting to the Head of Local Pharmacovigilance and also having a functional link with the European Economic Area Qualified Person for Pharmacovigilance (EEA QPPV - dotted line reporting). The LPV Director (deputy local person responsible for pharmacovigilance) is responsible for maintaining an appropriate local PV system and for performing PV activities as described in PHARMA-SOP-106. This individual will be responsible for helping to shape and execute the local pharmacovigilance strategy, driving compliance with regulatory requirements, and fostering a culture of safety excellence within the organization. This role will work closely with medical affairs colleagues and cross functional colleagues such as Global Safety, Regulatory Affairs, Field employees, and Market Access. 

Primary Responsibilities 

• Lead the local PV function to ensure the timely receipt and accurate reporting of all safety issues within the portfolio, in compliance with internal procedures and local regulations 

• Maintain oversight of safety risk management and of all pharmacovigilance activities in the territory 

• Prepare and maintain local PV procedures in compliance with Global SOPs and local regulations  

• Ensure that all Servier Pharmaceuticals employees and collaborators receive an appropriate level of PV training, adapted to their role, and which will enable them to identify and process PV information appropriately 

• Hire, develop, and retain a high-performing pharmacovigilance team. Oversee the PV requirements for contracts governing Investigator-sponsored studies (ISS) and other post-marketing collaborations and initiatives 

• Ensure pharmacovigilance compliance and inspection readiness across all affiliate functions 

• Participate in inspections performed by Regulatory Agencies and in internal PV Audits 

• Other responsibilities as described in PHARMA-SOP-106 or as directed by the functional management. 

Specific Responsibilities for Post-Marketing Pharmacovigilance 

• Ensure implementation of a local Quality Management System (QMS) in line with the global and local pharmacovigilance legislation, quality documents, and local needs; monitor the local quality document update timelines 

• Ensure collection, review, and follow-up of local PV information received from all post-marketing sources (spontaneous, solicited, literature, regulatory) and transmission of accurate and complete cases to Global Safety (GS), in compliance with the timeframes established in PHARMA-SOP-005; monitor the timelines of transmission  

• Ensure collection, review and follow up of safety information for products available under Early Access Programs (i.e. compassionate use) and transmission to Global Safety  

• Ensure direct contact with the Healthcare Professionals (HCP) to accurately document the PV cases, where necessary, and monitor the follow-up requests timelines 

• Electronic submission of ICSRs to the FDA, maintaining a log of data collected and transmitted to the Regulatory Agency, and monitoring compliance of ICSR submissions 

• Ensure that the information on the risk minimisation measures is delivered to all Servier staff as well as to HCP if applicable, in collaboration with the responsible person for Regulatory Affairs 

• Ensure screening of local scientific journals not indexed in any of the international literature databases and collection of the corresponding safety information 

• Review of the Post Authorization Programs with regards to collection, notification and management of safety data, considering the Risk Management Plan (if applicable) and the type of program 

• Ensure oversight of signal evaluation report posted in WRA Portal by Global Safety 

• Ensure the PV training of local employees and collaborators; KPI related to affiliate's employee PV training will be documented and provided to the EEA-QPPV for oversight 

• Ensure compliance with the local regulatory requirements and screening of regulatory intelligence 

• Participate in establishing PV agreements with partners and PV provisions for contracts with sponsor-investigators and service providers 

• Be informed of all local contracts with pharmacovigilance impact  

• Monitor the compliance of any locally outsourced PV activity 

• Ensure monthly reconciliation with functions responsible for products complaints/ quality defects and medical information 

• Ensure monthly reconciliations with other Servier functions and with service providers that can be sources of PV information 

• Maintain a list of the internet and digital media websites existing in the territory and share this information with the Global Safety International Unit upon request 

• Participate in internal audits of the local system of pharmacovigilance and in inspections performed by the Regulatory Agency (in collaboration with the concerned departments); implement the CAPA plan within the defined timelines 

• Archive local PV documents (safety/ICSRs data and records) according to local pharmacovigilance regulatory requirements and data protection rules 

• Set up and maintain a Business Continuity Plan (BCP), in collaboration with the dotted line manager (including management of ICSRs and a local 24/7 system to collect any safety information). 

Education and Required Skills 

• Medical doctor (preferred) or clinical pharmacist with broad specialty and experience  

•  8+ years of experience in pharmacovigilance within the pharmaceutical or biotechnology industry 

• Strong leadership skills 

• High personal ethical standards and strict sense of confidentiality 

Excellent analytical and critical investigative skills 

• Capacity to synthesize complex data 

• Exceptional organizational and project management skills, with the ability to handle multiple complex priorities and deadlines 

• Exceptional communication and presentation skills with the ability to distill complex safety data into actionable insights 

• Experience managing teams, demonstrated cross-functional leadership skills, and the ability to thrive within a matrix organizational structure 

• Experience in people management and development   

Travel and Location 

• Boston-based preferred (onsite in Seaport office 2-3x per week) 

• Minimal travel as required