Senior Specialist, Regulatory & PV Network

Job not on LinkedIn

🔥 0 minutes ago

🌐 Serbia, Czechia – Remote

🇷🇸 Serbia – Remote 🇨🇿 Czechia – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 17%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Act as Local Contact Person for Pharmacovigilance for the designated country • Lead and functionally represent medium/high-complexity projects • Coordinate and manage regulatory deliverables and drive teams to meet targets and procedures • Develop regulatory and PV strategy and manage project setup activities • Provide strategic input to internal and external customers • Identify and address risks through preventive measures • Resolve performance issues and delivery failures • Collect, review, track and maintain LCP CVs, job descriptions, training records, contact details and monthly reports • Ensure LCP training assignments and compliance • Communicate project tasks and time allocations to team members • Monitor project budgets, hours spent versus budgeted hours, and escalate out-of-scope work • Support proposal development, budgets and business development meetings • Prepare client invoices and review/approve vendor project invoices • Train, coach and mentor junior staff • Maintain professional relationships with internal and external contacts locally and internationally • Monitor changing regulatory legislative requirements and maintain the regulatory intelligence database • Support audit/inspection preparation and provide department representation • Track LCP KPIs and prepare monthly summary reports • Provide vendor performance feedback • Contribute to department/company initiatives and design or review SOPs, working practices and guidance

🎯 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 • Proficient in the official language of the country in which they are based • Good planning and organizational skills • Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment • Good attention to detail

🏖️ Benefits

• Remote work opportunity • Collaborative and supportive team environment • Flexible work culture • Growth and professional development opportunities • Training, coaching and mentoring opportunities • Opportunity to contribute to company initiatives and SOPs/working practices/guidance • Work with a global team across Europe, North America, South America, Asia and Australia • Opportunity to help bring safe and effective pharmaceutical treatment to patients around the world