Senior Specialist, Regulatory & PV Network

Job not on LinkedIn

🔥 0 minutes ago

🇭🇷 Croatia – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 16%

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.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• Develop regulatory strategy based on regulatory requirements • Drive regulatory and pharmacovigilance deliverables according to established plans • Act as Local Contact Person for Pharmacovigilance for the designated country • Lead and represent medium/high-complexity projects and coordinate regulatory deliverables • Develop strategy and manage project setup activities, including project management plans, joint operating procedures, POAs and core documents • 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 records, training records, contact details and monthly reports • Ensure correct LCP training assignment and compliance • Monitor project budgets, hours and out-of-scope work • Support proposal development 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 • Monitor changing regulatory requirements and maintain the regulatory intelligence database • Support audit and inspection preparation • Track LCP key performance indicators and prepare monthly reports • Provide vendor performance feedback • Contribute to department/company initiatives and 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 availability • Flexible work environment • Growth opportunities • Collaborative and supportive team culture • Belonging and inclusive workplace • Professional development through training, coaching and mentoring • Exposure to global work and international collaboration