Job Description

Overview

Director, Local Pharmacovigilance (LPV) role at Servier Pharmaceuticals . The LPV Director (deputy local person responsible for pharmacovigilance) is part of the Medical Affairs Group, reporting to the Head of Local Pharmacovigilance and having a functional link with the European Economic Area Qualified Person for Pharmacovigilance (EEA QPPV). The LPV Director is responsible for maintaining an appropriate local PV system and for performing PV activities described in PHARMA-SOP-106. This role helps shape and execute the local pharmacovigilance strategy, drives regulatory compliance, and fosters a culture of safety excellence. Works closely with Medical Affairs, Global Safety, Regulatory Affairs, Field employees, and Market Access.

Primary Responsibilities

• Lead the local PV function to ensure 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 all pharmacovigilance activities in the territory
• Prepare and maintain local PV procedures in compliance with Global SOPs and local regulations
• Ensure that Servier Pharmaceuticals employees and collaborators receive an appropriate level of PV training, adapted to their role, to identify and process PV information
• Hire, develop, and retain a high-performing pharmacovigilance team. Oversee 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 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 from post-marketing sources (spontaneous, solicited, literature, regulatory) and transmission of accurate and complete cases to Global Safety (GS), per PHARMA-SOP-005; monitor transmission timelines
• Ensure collection, review and follow-up of safety information for products under Early Access Programs (compassionate use) and transmission to Global Safety
• Maintain direct contact with Healthcare Professionals (HCP) to document PV cases, as needed, and monitor follow-up requests timelines
• Submit ICSRs to the FDA, if not performed centrally, maintain a log of data collected and transmitted, and monitor ICSR submission compliance
• Communicate risk minimisation measures to all Servier staff and to HCPs as applicable, in collaboration with Regulatory Affairs
• Screen local scientific journals not indexed in international databases and collect corresponding safety information; review Post Authorization Programs for safety data management
• Oversee signal evaluation reports posted in WRA Portal by Global Safety
• Provide PV training for local employees and collaborators; document KPIs related to affiliates PV training for oversight
• Ensure regulatory compliance 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 PV impact; monitor compliance of locally outsourced PV activity
• Ensure monthly reconciliations with product complaints/quality defects and medical information functions
• Ensure monthly reconciliations with other Servier functions and service providers that contribute PV information
• Maintain a list of internet and digital media sources in the territory and share with Global Safety International Unit as requested
• Participate in internal PV system audits and regulatory inspections; implement CAPA within defined timelines
• Archive local PV documents (safety/ICSR data and records) per local PV regulatory requirements and data protection
• Set up and maintain a Business Continuity Plan (BCP), in collaboration with the dotted line manager (including 24/7 system for collecting 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 confidentiality
• Excellent analytical and investigative skills
• Ability to synthesize complex data
• Exceptional organizational and project management skills with the ability to handle multiple priorities and deadlines
• Excellent communication and presentation skills with the ability to distill complex safety data into actionable insights
• Experience managing teams, cross-functional leadership, and thriving in a matrix organization
• Experience in people management and development

Travel and Location

• Boston-based, onsite in Seaport office 2-3x per week
• Minimal travel as required

Serviers Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We foster an environment that maintains equitable treatment for all and welcome applicants who are passionate, committed, and innovative. We encourage candidates to apply to open roles and consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Seniority level

• Director

Employment type

• Full-time

Job function

• Science, Other, and Research

Industries

• Pharmaceutical Manufacturing and Biotechnology Research

Job Tags

Similar Jobs