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Servier Pharmaceuticals · 2 weeks ago

Director, Local Pharmacovigilance

Boston, MA

Contract

Hybrid

Director/Executive

$205K/yr - $245K/yr

8+ years exp

Servier Pharmaceuticals is a Boston-based, commercial-stage biopharmaceutical company focused on advancing cutting-edge science and addressing underserved therapeutic areas. The Director, Local Pharmacovigilance will lead the local pharmacovigilance function, ensuring compliance with regulatory requirements and fostering a culture of safety excellence within the organization.

Health CareMedicalPharmaceutical

H1B Sponsor Likely

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

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)

Qualification

Pharmacovigilance experienceRegulatory complianceLeadership skillsMedical doctorAnalytical skillsProject managementCommunication skillsTeam managementOrganizational skillsConfidentiality

Required

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

Preferred

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

Minimal travel as required

Benefits

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 programs among other great benefits

Company

Servier Pharmaceuticals

Servier Pharmaceuticals is a pharmaceutical company dedicated to therapeutic progress to serve patient needs.

Founded in 2018

Boston, Massachusetts, USA

201-500 employees

https://www.servier.us/

H1B Sponsorship

Servier Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (4)

2023 (4)

2022 (3)

2021 (15)

2020 (2)