Head of Compliance
jobsmatter
Local Contact Person – Pharmacovigilance and Regulatory Affairs, English & German
ERGOMED
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇩🇪 Germany
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements
- Prompt and effective communication with local regulatory authorities
- Provision of local regulatory intelligence screening and expert advice
- 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
- Preparation and collection of documentation for submissions to the regulatory authorities
- Review and linguistic input on local Product Information and Mock-ups
- 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
- 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
Requirements
- Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
- Minimum 3 years within pharmaceutical or CRO industry or regulatory authority
- Minimum 2 years within LCPPV role, or relevant pharmacovigilance experience in safety-related position
- Pharmacovigilance training and/or working experience and other educational or professional background as required by local regulations
- Prior experience in Regulatory Affairs is preferred but not mandatory
- Expert knowledge of ICH GVP and relevant local legislation/ regulatory requirements in territories of competency
- Proficiency in English and German, both written and verbal
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmacovigilanceregulatory affairsADR reportingICSR collectionrisk minimizationlocal pharmacovigilance systemliterature screeningcompliancequality assuranceICH GVP
Soft skills
communicationexpert adviceoversightsupportdocumentation managementteam collaborationproblem-solvingattention to detailorganizational skillsauditing
Certifications
Bachelor's Degree in Life SciencesBachelor's Degree in ChemistryBachelor's Degree in Nursingpharmacovigilance training