Pharmacovigilance Manager for UK, Ireland and Malta

Pharmacovigilance Manager for UK, Ireland and Malta

Baxter International

London-Newbury, United Kingdom

The Pharmacovigilance Senior Manager for UK, Ireland & Malta is responsible:

In the main country (UK):

  • In collaboration with Global Patient Safety (GPS), the Cluster Director Pharmacovigilance and the Eu QPPV, to maintain an efficient Pharmacovigilance system meeting the European and National regulations and in compliance with the Baxter Pharmacovigilance procedures,
  • To act as the local contact person for NHS Homecare
  • To work closely with the PV team in UK
  • To supervise PV activities and ensure alignment and sharing according to the cluster model
  • To ensure appropriate contacts with the country General manager and other interfaces not limited to country Regulatory Affairs, Country Quality Assurance, Business Units and with HCP, Competent authorities (MHRA, HPRA).

In the associated countries of the Cluster (Ireland, Malta):

  • To coordinate the maintenance of an efficient PV system according to national regulations and to support answering PV related questions.
  • To supervise PV activities and ensure alignment and sharing according to the cluster model
  • To provide any guidance as needed
  • To work closely with the PV team in Nordics

ESSENTIAL DUTIES AND RESPONSIBILITES

The PV Manager is accountable and responsible for the following activities:

1. Oversight and Team management

  • To have an oversight of all PV activities performed in the Cluster,
  • To alert the cluster Director Pharmacovigilance, the Eu QPPV and GPS about any safety related issues without delay,
  • To be involved the communication on PV topics with MHRA and HPRA and coordinate answers in cooperation with the cluster PV Director, GPS and the Eu QPPV,
  • To collaborate with PV members from other clusters under direction from the cluster Director Pharmacovigilance and with the Global PS organization, as appropriate,
  • To provide the team with appropriate guidance for alignment and improvement of the local PV system,
  • To provide the team with an appropriate training and coaching when necessary,
  • To support the cluster PV Director for preparation of PMOs/PMPs aligned with Global Objectives and performance assessment.

Activities related to UK, Ireland & Malta:

2. Local contact person for Pharmacovigilance for national competent authorities:

  • To act as the contact point for MHRA & HPRA regarding any Pharmacovigilance safety issue,
  • To fulfill responsibility of local contact person/ National qualified person for Pharmacovigilance according to country legislation,
  • To provide the National CA with any information relevant to the benefit/risk evaluation of Baxter products in collaboration with the Eu QPPV, the PV Cluster Director and the GPS organization.

3. ADR Reporting:

  • To maintain a system for ADR handling and supervise the collection, documentation, follow-up of adverse drug reactions (ADRs) and other pharmacovigilance information (e.g. pregnancy cases, lack of efficacy, medication error….) from all sources according to SOPs,
  • To coordinate the answer to any questions from Competent Authorities in collaboration with the EU QPPV and the GPS organization,
  • To coordinate the answer to safety questions from the Health Care Professionals with the support of the GPS organization, and Medical affairs if necessary.

4. Clinical trials activities:

  • If states in the protocol, to supervise the process of SAEs and transmission to the GPS according to SOPs,
  • To ensure SUSARs and new events are notified to the Health Authorities according to the national regulations.

5. PSURs:

  • According to the process established at EU level, to validate the comparative table prepared by RA to put CCDS/CCSI/RSI and the local SPC in conformity.

6. Other local PV activities:

  • To perform surveillance activities for any new potential safety information (e.g. similar AEs reported in a cluster of reports or multiple cases for one batch received in a short time frame) and escalate as per procedures
  • To collaborate with the EMEA PV agreements team to ensure that any Agreement with Third Party include appropriate PV clause
  • To support the EMEA PV Agreement team in the implementation of local PSPs/MRPs
  • To screen the website of MHRA and HPRA
  • To inform GPS and EU QPPV on relevant changes concerning National regulation,
  • To be a member of the local pharma association and participate in meetings,
  • To participate to 24 hours coverage as required

7. Interactions with other relevant functions:

  • To implement and coordinate corrective actions in case of internal audits and or external inspections in cooperation with the cluster PV Director and GPS/ EU QPPV,
  • To support the Cluster PV Director in the management of a crisis upon request

8. Training:

  • To perform trainings as required and keep up to date personal training records.
  • To coordinate and ensure appropriate training on PV is delivered to new employees, HCP facing employees, partners and vendors.
  • To keep up to date records of the internal Pharmacovigilance trainings made to Baxter employees, partners or vendors

9. Procedures:

  • To support the team for creation, issuance and implementation of local Pharmacovigilance SOPs and Job Aid.
  • To implement global Pharmacovigilance SOPs.

10 Compliance:

  • To closely monitor local compliance and ensures all efforts are made to achieve high compliance rates.
  • To help in the resolution of non conformance Reports

Activities related to Malta :

  • To collaborate with the distributor according to the SDEA in place
  • To closely monitor local compliance

Qualifications

  • The function requires a degree in Medicine or Pharmacy.
  • Minimum of 5 year professional experience in PV is required in this field of activity.

SKILLS

Additional knowledge or skills gained through a combination of academic study, job experience is required, e.g.:

  • Outstanding team management and leadership skills.
  • Ability to communicate efficiently and in writing in local language as well as in English.
  • Good negotiation skills.
  • Ability to liaise with the different functions ie GM, Regulatory Affairs, Country Quality Assurance, businesses, Legal Affairs.

PROBLEM SOLVING

The problem solving capabilities for this position is:

Regarding: people

  • To be effective in the communication with the Health Authorities and Health Care Professionals,
  • To be effective in the interaction with the different functions,
  • To be effective in managing people.

Regarding: technical

  • A perfect understanding of existing regulations,
  • A perfect understanding of the SOPs,
  • A good knowledge of the Baxter products.

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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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