Job Description

Director, Local Pharmacovigilance

About Servier

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cuttingedge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision.

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 PHARMASOP106. This individual will help shape and execute the local pharmacovigilance strategy, drive compliance with regulatory requirements, and foster a culture of safety excellence within the organization. The role works closely with medical affairs colleagues and crossfunctional 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 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 highperforming pharmacovigilance team. Oversee the PV requirements for contracts governing InvestigatorSponsored Studies (ISS) and other postmarketing 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 PHARMASOP106 or as directed by the functional management

Specific Responsibilities for PostMarketing 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 followup of local PV information received from all postmarketing sources (spontaneous, solicited, literature, regulatory) and transmission of accurate and complete cases to Global Safety (GS), in compliance with the timeframes established in PHARMASOP005; monitor the timelines of transmission
• Ensure collection, review and followup of safety information for products available under Early Access Programs (i.e., compassionate use) and transmission to Global Safety
• Ensure direct contact with Healthcare Professionals (HCP) to accurately document the PV cases, where necessary, and monitor the followup requests timelines
• Electronic submission of ICSDs 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 PostAuthorization 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 EEAQPPV 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 sponsorinvestigators 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 product 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 ICSDs 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 crossfunctional leadership skills, and the ability to thrive within a matrix organisational structure
• Experience in people management and development

Travel and Location

Bostonbased preferred (onsite in Seaport office 23x per week)

Minimal travel as required

Serviers Commitment

Servier is committed to modelling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

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

Salary Range

The salary range for this role is $205,000 - 245,000. An employees pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organisational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for ShortTerm and LongTerm incentive programmes. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programmes among other great benefits (all benefits are subject to eligibility requirements). For more information on our benefits, please visit this link.

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