PrimeVigilance Hiring for Project Services Manager at Mumbai, Maharashtra Full Time

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 the Guildford office. 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