Senior Specialist, Regulatory & PV Network (Delivery)

Role Overview

A delivery focused role combining Regulatory and Pharmacovigilance (PV) project management and coordination, responsible for ensuring timely and compliant execution of regulatory and PV activities across assigned projects.

The Senior Specialist will also act as Local Contact Person for Pharmacovigilance (LCPPV) for the designated country.

 

Core Responsibilities
Project Management

• Manage medium/high-complexity regulatory and PV projects, ensuring delivery against timelines, scope, and quality
• Oversee project setup, plans, and milestones, and coordinate across clients, LCP network, vendors, and internal teams
• Identify and mitigate delivery risks

PV & Compliance

• Act as LCPPV, ensuring compliance with local PV requirements and inspection readiness
• Support audits and inspections

Team & Operations

• Oversee LCP documentation (CVs, training, KPIs) and ensure training compliance
• Contribute to process improvements and standardization
• Support and guide junior staff

Financial & Operational Oversight

• Track scope, timelines, and budget, including OoS activities
• Support invoicing and monitor project performance, escalating deviations

 

• Bachelor's Degree in Pharmacy
• Strong experience within pharmaceutical or CRO industry or Regulatory body
• Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency
• PV training and/or working experience and other educational or professional background as required locally
• Fluent in English, both written and verbal
• Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance
• Proficiency in German, French, or Italian is a plus but not mandatory
• Good planning and organizational skills
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Good attention to detail

Why PrimeVigilance

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

We offer: 

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth 
• Friendly, supportive working environment 
• Opportunity to work with colleagues based all over the world, with English as the company language 

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

• Quality 
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging 
• Collaborative Partnerships

We look forward to welcoming your application. 

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