Project Services Manager

  Pharmacovigilance

Job title: Project Services Manager

Company: PrimeVigilance

Job description: Company Description

PrimeVigilance, an Ergomed brand , was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects.

PrimeVigilance is continuing to expand and is looking for a Project Services Manager to join the team in India. This is a newly created role that will be assigned to internal business improvement initiatives. This role will address project management, business analysis and computer system validation, creating all necessary project documentation with input from business and IT representatives.

Job Description

Safety System projects, mainly migration projects, shall be assigned a Project Services Manager. The Project Services Manager will be accountable for activities from project planning till completion. The role covers three key responsibilities, as below, in the project team:

Project Management Responsibilities

Deliverables in compliance with the company’s Stage and Gate Project Methodology, migration process, including but not limited to:

  • Project Schedule
  • End of Project Stage Reviews
  • Facilitation of Project Team Meetings
  • Status Reports including presentations to senior management

Business Analyst Responsibilities

Producing project and validation deliverables including

  • Business Case
  • Business Process Maps
  • User Requirements Specifications
  • Business Process Risk Assessment

Computer System Validation Lead Responsibilities

Producing validation deliverables in compliance with the companies CSV procedures including:

  • Validation Plan
  • OQ and PQ Test Scripts
  • Training Plan
  • ERES Risk Assessment
  • GDPR Assessment
  • Deployment Plan
  • Data Migration Plan
  • Validation Summary Report

All deliverables will require the Project Services Manager to obtain input from the business /user representatives, IT and potentially the software vendor through focus groups, interviews, or other data gathering techniques. The Project Services Manager will be required to ensure the data gathered has the appropriate level of detail and is concise and unambiguous. They will need to ensure all documentation is correctly cross referenced with minimal duplication and is in the correct format according to the company’s templates.

Qualifications

Education:

Life Science or Project Management, Business Analysis or IT Development Related Degree

Experience:

  • Good knowledge of Pharmacovigilance, specifically handling migration projects
  • Experience of working on business improvement initiatives with a technology component.
  • Working knowledge of Computer System Validation (ISPE GAMP).

Special Skills:

  • Ability to write clear unambiguous statements and complicated documentation.
  • Ability to think logically and innovatively
  • Excellent listening and deductive reasoning skills.
  • Excellent meeting facilitation skills.
  • Ability to communicate clearly and professionally to senior management including the Board and clients.

Language Skills:

Excellent verbal and written English language skills.

PC Skills:

Microsoft Project, Excel, Word, Power Point, Visio

Additional Information

Our Offer

  • Competitive salary
  • Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
  • Multicultural environment, English as a company language
  • Strong emphasis on personal and professional growth
  • Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
  • Friendly working environment with several social events per year

Expected salary:

Location: Mumbai, Maharashtra

Job date: Thu, 24 Feb 2022 23:17:18 GMT

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