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Associate Manager, PVQA

4 months ago

Mumbai, India Astellas Pharma Full time

Purpose & Scope:


Pharmacovigilance (50%)


In coordination with the PV Affiliate Lead/Drug Safety Officer (DSO):


This function is responsible for maintenance of excellence in Pharmacovigilance (PV) activities at the local affiliate. Reports to the PV Affiliate Lead/DSO or delegate. In addition, this role contributes to the successful implementation and execution of the PV Affiliate Management Mission and Strategies, objectives and 3–5-year strategic plan.


Responsible for executing procedures to ensure compliance with both local and regional PV regulations and Astellas global and regional policies and procedures.


Responsible for executing of assigned PV tasks in absence of PV Affiliate Lead/Drug Safety Officer (DSO).


Works extensively within affiliate and with PV-Affiliate Management Function colleagues on matters relating to operational management and compliance that are impacting PV.


In addition, with a focus on training and case intake this function will be responsible for executing Pharmacovigilance activities at affiliate level,


Responsible for executing PV activities to maintain the local PV System, ensuring oversight, PV Compliance and PV Quality.


Quality Assurance (50%)


The Associate Manager Astellas India PV/QA position will be responsible for Collaboration in further setup, maintenance and implementation of the pharmaceutical quality management system as well as performance of several measures to secure the quality management of Astellas India and its third parties.


Perform Quality Assurance activities on behalf of the Affiliate in its capacity as wholesaler and Marketing Authorization Holder


Ensure all Astellas products, personnel and third parties conform to local and company quality assurance requirements


Ensure implementation and maintenance of a Quality Management System, which is compliant with GDP Guidelines, local legislation and Astellas corporate quality assurance requirements and is proportionate to the scope of wholesale distribution and Marketing Authorization Holder activities undertaken by or on behalf of the affiliate.


Maintain independence with regards to QA decision making within the affiliate.


Essential Job Responsibilities:


Pharmacovigilance


Strategy Development and Execution

Contributes to the implementation of 1–3-year Global, Regional Affiliate Management and Local specific objectives and plans as part of the overall PV strategy and plans. Supports in the successful execution and implementation of Global Affiliate Management vision, mission, objectives and plans.

Provides input to PV leadership and strategic direction to the local PV dept in the country/affiliate. Coaching/mentoring of the local PV dept staff employees (if applicable).


The Affiliate Associate PVQA Manager is responsible for:


  1. General department
  2. Management of Product Safety Information
  3. PV Quality and Compliance
  4. Maintenance of PV System and Oversight Responsibilities
  5. People and Organizational Management Due Diligence activities for local country licensing agreements
  6. Training
  7. Quality Assurance


Qualifications:


Required

  • Minimum BA/BS (Pharmacy, Medical or Biomedical/Life Sciences preferred) preferably with an advanced professional degree
  • Track record of demonstrable and relevant minimum 3 years’ experience within PV and/or combined PV/RA/QA; to include direct contact and engagement with national competent authorities. 1 Year people/project management experience preferred.
  • Good understanding of establishing and maintaining (GxP) Quality Management Systems.
  • Awareness of local industry code(s) of practice and local and/or regional PV regulations and guidelines.
  • Experience in supporting a PV system in at least one single country; low complexity, low case volume.
  • Awareness and experience with some aspects of a PV quality management system
  • Proficiency in local language and business English language (written, verbal, presentation, facilitation)
  • If applicable: up to 30% travel required


Skills and competencies:

  • Good communication and negotiation skills and willing to build collaboration relationships.
  • Good problem-solving and solution-oriented skills.
  • Independent working – plans, schedules and arranges own activities to achieve desired results.
  • Ability to work with all team members in a MATRIX structure


Preferred

  • Project management experience (scope, interdependencies, budgeting, critical path analysis, reporting etc).
  • Fluency in an additional language is preferred