ERGOMED

Regulatory and Pharmacovigilance Specialist, 2 Years Fixed Term Contract

ERGOMED

full-time

Posted on:

Location Type: Remote

Location: Bosnia and Herzegovina

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About the role

  • Provide the strategy based on regulatory requirements and for completing regulatory and PV deliverables based on an established PV and regulatory plan.
  • 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.
  • Act as Local Contact Person for Pharmacovigilance for the designated country.
  • Assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables.
  • 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.
  • 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.

Requirements

  • Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
  • Previous experience within the pharmaceutical/CRO industry
  • 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
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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
PharmacovigilanceProject ManagementRegulatory ComplianceRisk ManagementData ReviewTraining ComplianceInvoice Management
Soft Skills
LeadershipInterpersonal SkillsOrganizational SkillsAttention to DetailCommunication SkillsProblem SolvingClient Management
Certifications
Bachelor's Degree in ChemistryBachelor's Degree in Life SciencesBachelor's Degree in Nursing