Director, Local Pharmacovigilance

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Type of Contract : Full-time Employment / Unlimited

Job Requisition ID : 9308

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 cutting-edge 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 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

Servier’s Commitment

Servier is committed to modeling 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, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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