Head of Country PV Portugal

Head of Country PV Portugal

Bristol-Myers Squibb

Paco De Arcos, Portugal

Objective of the job

Holds primary responsibility for all country pharmacovigilance (PV) core activities, acting as the point person with the Portuguese Health Authority on safety related matters. Leads and brings to resolution with all appropriate functional groups, locally and globally, all product safety related issues that arise in Portugal, ensuring audit readiness and leading cross-functional teams to ensure that internal and external inspections are conducted effectively.

Key Responsibilities and Major Duties

  • Risk management plans
  • Provision of safety information
  • Implementation of PV Audit and Inspection Readiness
  • Planning, processing and reporting of Aggregate Reports to HA and EC (as required)
  • Maintenance of PV Awareness and Training
  • Implementation of Pharmacovigilance Agreements
  • Collection, follow-up and forwarding of spontaneous, literature, solicited, post-marketing AE cases
  • Submission of single cases to local Health Agencies(HA) and Ethics Committees (as required)
  • Local Market Safety Data Quality

Requirements and Competencies

  • University degree in Health or Life Science
  • At least 3 years of experience in a similar field within the pharmaceutical industry, preferably in Portugal
  • Effective organizational, facilitation, interpersonal and communicating skills with cross functional teams
  • Excellent working relationship with the local Health Authorities
  • Clarity and consistency to achieve alingment of stakeholder activities regarding safety risk related requirements internally (local/regional/HQ) and externally (HAs, BPs)
  • Subject matter expert in local legislation
  • Contributes actively to the implementation of new legislation and GPV&E procedures/systems
  • Monitors and ensures adherence to local regulatory requirements, high quality safety documentation and PV compliance
  • Leads cross-functional teams for Risk Management and other safety related matters
  • Effective decision making and a problem-solving approach
  • Appropriately consults or escalates and ensures management of LM PV Core Activities
  • Ability to manage multiple tasks and utilize effective problem-solving approaches and independently follow up and resolves outstanding issues

*Minimal travel required

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© EuroJobsites 2019

EuroJobsites is a UK 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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