CHC Regional Pharmacovigilance Head, Europe

CHC Regional Pharmacovigilance Head, Europe

Sanofi

Multiple Locations

About the job

Main responsibilities:

  • Is responsible for the PV in Europe and continuously maintains a robust working relationship with the European Qualified Person for Pharmacovigilance and the organization within CHC PV;
  • Ensures full compliance with all global, regional, and local regulatory requirements and company standards for safety data management and reporting, for all CHC registered and in development products as well as in the launch- and post-marketing phases;
  • Leads and develops the team of CSHs in the assigned region and is responsible to perform an effective oversight and management of the PV activities delegated to distributors and/or PV vendors in respective countries within assigned Region;
  • Ensures that the local/regional legal requirements as well as company PV standards and policies are implemented and followed by all distributors and/or PV vendors in a compliant and timely manner to warrant safe and appropriate use of CHC products on the market in the assigned Region;
  • Serves as the key contact point for the Distributors and/or PV vendors of the assigned Region for the delegated PV related activities at country level, including but not limited to case management, local safety surveillance, periodic safety reports, signal detection, risk management and risk mitigation activities, patient support programs and market research programs, safety related authority requests and also between Distributors and/or PV vendors and the CHC Global teams, as required coordinating with other CHC regional functions (e.g. regulatory, medical) for PV related aspects;
  • Ensures that SDEAs with distributors and/or PV agreement with PV vendors are established, maintained, and revised in due timelines. Ensures that all PV activities described in the SDEAs and/or PV agreements are followed to assure ongoing compliance;
  • Performs other activities which require a coordination role e.g. new process implementation, communication to Distributors, implementation of additional Risk Minimization Measures and their tracking as applicable, supports PV Inspection and Audit preparation, conduct and follow-up activities etc.;
  • Consults with distributors that, where needed, the local PV System Master File is developed and maintained in accordance with the global standards;
  • Ensures that further to PV audit and inspection observations for the CHC products, CAPAs and effectiveness checks have been implemented in close interaction with distributor and/or vendor and with Global/Regional CHC Functions, as required;
  • Manages contract/work order with regional PV vendors, monitor the appropriate execution of outsourced activities and take the appropriate measures in case of deviations;
  • Strives for continuous improvement, harmonization, and simplification of processes/PV activities in the assigned region;
  • Aligns with other Regional PV Heads for simplification and standardization.

About you

Experience:

  • Extensive knowledge of pharmacovigilance regulations at National/Regional level;
  • Knowledge of International pharmacovigilance requirements, with experience in their practical application. Compliance focused;
  • Experience interacting with internal auditors and health agency inspectors;
  • Experience with pharmacovigilance systems and safety related product management in both clinical development and marketed products;
  • Experience with distributors/PV vendors management;
  • Experience working in multinational environment, across diverse cultures;
  • Working knowledge of PV Systems, central and local PV operations, PV processes, regulatory compliance, standardization, and Pharmacovigilance Agreements in partnerships;
  • Knowledge on pharmacovigilance tools and procedures.

Competencies:

  • Has knowledge of local legal PV requirements in the assigned region and ensures that these requirements are provided to global PV functions;
  • Leadership: Management of people (including remote people management), development and coaching, performance management;
  • Collaboration and Partnering: Demonstrates advanced ability to work in partnership with others (internally and externally) to accomplish quality goals; possesses advanced leadership skills;
  • Communication Skills: Demonstrates advanced communications skills to convey and receive information. Demonstrates advanced oral and written communications skills;
  • Problem Solving: Demonstrates expert level skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction;
  • Strategic Thinking: Demonstrates advanced skills to drive change that enhances processes within the company or cross-functionally within Research and Development, Manufacturing, Global Health that improve quality and/or add value to the business;
  • Project Management: Demonstrates expert ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations;
  • Decision Making: Demonstrates advanced skills to utilize knowledge, networks, and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.

Additional Competency requirements:

  • Excellent organizational and planning capabilities;
  • Strong negotiation and interpersonal skills;
  • Inter-cultural skills/ability to work across cultures and functions;
  • Team player.

Education:

  • Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences PhD, MPh or Master’s Degree with more than five years of supervisory experience, and 5 or more years working with/or collaborating across multiple countries within a region.

Languages:

  • Fluent in English (written and spoken);
  • Knowledge of other European languages is an asset.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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