Senior Expert

1 week ago

Bengaluru, Karnataka, India Merck Specialities Pvt. Ltd. Full time ₹ 15,00,000 - ₹ 20,00,000 per year

Your Role:

As Senior Expert Regional Pharmacovigilance in the Process Management and Process Excellence Team in RQS Operations (Regulatory, Quality and Safety) you will focus on simplifying the RQS process landscape. You will implement a risk-balanced approach to process management and, as an essential partner to RQS functions (and beyond) you will drive an agenda of continuous improvement by driving the following key activities:

  • Supporting PV activities for different countries in close collaboration with Global Patient Safety (GPS) Team and other stakeholders within RQS Operations.
  • Maintaining the local PV system and its documentation in local PV System Master Files in accordance with global / local legislation and company standards.
  • Authoring and/or co-ordinating and reviewing local Risk Management Plans.
  • Driving improvement and automation initiatives, including selecting and implementing suitable AI-based tools for simplification of the processes in scope.
  • Maintaining audit- and inspection-readiness at all times of the processes and documentation in scope of the role.
  • Applying a risk-based approach to prioritization of tasks and projects.

Who You Are:

Minimum Requirements:

  • Master's degree or equivalent in pharmacy or life-sciences
  • Minimum of 8 years' experience in the pharmaceutical or CRO industry, covering at least three of the following areas within post-marketing pharmacovigilance:
  • Set-up and maintenance of a PV system (global / local / regional), authoring / review of local PV System Master files.
  • Track record of acting as Business Process Owner for a PV-relevant process.
  • Proven successful interaction between local and global PV functions.
  • Thorough understanding of Safety risk management and implementation of additional Risk Minimization Measures
  • Proven successful involvement in audits and health authority inspections.

Preferred Requirements:

  • Licensed pharmacist or Ph.D. in life sciences.
  • Proven track-record of working in a global industry environment.
  • Ability to handle urgent priorities across different, requirements and time-zones.
  • Pro-active, solution-and customer- oriented mindset.
  • Excellent communication skills in English, written and spoken, other languages are an asset.
  • Ability to successfully work in a multicultural environment and to foster an atmosphere of mutual understanding.
  • Experience with AI Tools and project management are additional assets.

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