ERGOMED logo
ERGOMED

Global Provider of Expert, High-Quality Services to the Biopharmaceutical Industry. Your Full-Service Solutions Partner.

Local Contact Person – Pharmacovigilance, Regulatory Affairs

ComplianceComplianceFull TimeRemoteMid LevelTeam 1,001-5,000Since 1997H1B No SponsorCompany SiteLinkedIn

Location

Serbia

Posted

3 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree2 yrs expEnglish

Job Description

Local Contact Person – Pharmacovigilance, Regulatory Affairs

ERGOMED

• Prompt and effective communication with MAH and local regulatory authorities as required • Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements • Provision of local regulatory intelligence screening and expert advice for the responsible region(s) • Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations) • Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues • Support with development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations • Perform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety information • Maintain accurate records and documentation at local level • Provide support to the RA & PV Global operations team • Preparation and collection of documentation for submissions to the regulatory authorities • Review and linguistic input on local Product Information and Mock-ups • Ensure compliance with MAH's and PrimeVigilance's procedures • Support audits and Inspections • Handle local QA tasks such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local market

Job Requirements

  • Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
  • 2-4 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or regulatory environment
  • Good understanding of ICH GVP and local pharmacovigilance requirements (training or practical exposure)
  • Experience in case handling, literature screening, or local PV activities is preferred
  • Prior experience in Regulatory Affairs is preferred but not mandatory
  • Proficiency in English and additional language knowledge (i.e. French) is advantageous
  • Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint

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

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