Regulatory & Pharmacovigilance Senior Specialist

PrimeVigilance

1d • Remote

About The Position

PrimeVigilance (part of Ergomed Group) is a specialized mid-size pharmacovigilance service provider established in 2008, with global organic growth and staff across Europe, North America, and Asia. They offer services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance, supporting pharmaceutical and biotechnology partners across all therapy areas, including medical devices. PrimeVigilance invests in its staff through training and development, valuing employee experience, well-being, mental health, and work-life balance to ensure high-quality client service. The Senior Specialist, Regulatory and PV Network, is responsible for developing strategies based on regulatory requirements and driving regulatory and PV deliverables according to an established plan. This role serves as a liaison between regulatory and other functional areas, including external partners, clients, authorities, and consultants, for planning, organizing, and preparing regulatory deliverables. The Senior Specialist will also act as the Local Contact Person for Pharmacovigilance for the designated country.

Requirements

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
• 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
• Good planning and organizational skills
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Good attention to detail

Responsibilities

• Act as Local Contact Person for Pharmacovigilance for the designated country
• Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates
• With the help of a senior member of the team, develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs and core documents)
• Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures
• Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
• Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
• Ensure correct training assignment to and training compliance by the LCPs
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
• Prepare client’s invoices and review/approve vendors’ project invoices
• Provide training, coaching and mentoring to junior members of staff
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required
• Track LCPs' key performance indicators and prepare monthly summary reports
• Provide feedback on performance of vendors to aid their assessment
• Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.

Benefits

• 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
• Diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment
• Employee experience, well-being and mental health are valued
• Healthy work life balance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior