Specialist, Regulatory and PV Network

2 weeks ago

Belgrade, Central Serbia Ergomed Full time €40,000 - €60,000 per year

The Specialist, Regulatory and PV Network is responsible for providing the strategy based on regulatory requirements and for completing regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies.

The Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country.

Job Responsibilities

​​Role and Responsibilities​

  • Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
  • Provide intelligence on requirements and contribute to the development of the strategy and set up activities (Project Management Plan, joint operating procedures, POAs and core documents). Support identification of issues and corrective actions.
  • 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.
  • Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.
  • Provide Clients expertise and guidance at national level.
  • Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.
  • Prepare client's invoices and review/ approve vendors' project invoices.
  • Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
  • 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 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.
  • Communicate suggestions for changes to departmental/company processes/procedures.

  • Senior PV Specialist

    2 weeks ago

    Belgrade, Central Serbia ProPharma Full time $90,000 - $120,000 per year

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the...

  • Assistant, Regulatory

    2 weeks ago

    Belgrade, Central Serbia Ergomed Full time €20,000 - €30,000 per year

    Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and...

  • Senior Regulatory and Start Up Specialist

    2 weeks ago

    Belgrade, Central Serbia Precision for Medicine Full time €40,000 - €60,000 per year

    Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...

  • Network Engineer

    2 weeks ago

    Belgrade, Central Serbia Paysend Full time €60,000 - €90,000 per year

    About The Role: We are looking for a skilled Network Engineer to join our IT infrastructure team and take ownership of designing, deploying, and maintaining our global network systems. This role is crucial in ensuring high availability, performance, and security across both on-premise and cloud environments. The ideal candidate will have a strong background...

  • Senior Pharmacovigilance Physician

    2 weeks ago

    Belgrade, Central Serbia ERGOMED Full time €60,000 - €80,000 per year

    Company DescriptionPrimeVigilance (part of Ergomed Group), is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and...

  • Onboarding Specialist

    2 weeks ago

    Belgrade, Central Serbia Paysend Full time €40,000 - €60,000 per year

    About The Role: We're looking for an Onboarding Specialist that will be responsible for completing due diligence of new business clients and managing the ongoing due diligence for our existing business client base. You will also be responsible for aspects of compliance & regulatory reporting and in order to do this you will be working closely with our...

  • Pharmacovigilance Physician II

    2 weeks ago

    Belgrade, Central Serbia Ergomed Full time €40,000 - €80,000 per year

    Company Description PrimeVigilance (part of Ergomed Group), is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and...

  • Senior IP Network Specialist

    2 weeks ago

    Belgrade, Central Serbia CETIN Serbia Full time €104,000 - €130,878 per year

    About us:As a leading telecommunications infrastructure provider in the region, CETIN drives digital transformation with a strong presence across Bulgaria, Hungary, Serbia, and Slovakia. Through our subsidiaries, we deliver advanced technology solutions that empower connectivity and enable innovation.CETIN owns and operates some of the largest...

  • Billing Specialist

    2 weeks ago

    Belgrade, Central Serbia ProPharma Full time €45,000 - €55,000 per year

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the...

  • Senior Talent Acquisition Specialist

    2 weeks ago

    Belgrade, Central Serbia Flex Talent Network Full time $24,000 per year

    Location: Bangkok, Thailand (Relocation Required) Salary: Up to $2,000 NET/month Type: Full-time, Onsite ⸻ About the Role We are looking for a Senior Talent Acquisition Specialist to lead and execute full-cycle recruitment for global tech roles across multiple countries. Youll play a strategic role in identifying, engaging, and securing top talent in...