Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPVLCPRA) English & German
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Job Location:
Frankfurt am Main - Germany
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements. This dual-role position is responsible for executing PV and RA activities at the local level supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.
Main responsibilities
- 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 MAHs 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 MAHs and PrimeVigilances 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
Qualifications :
- Bachelors 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
Additional Information :
Why PrimeVigilance
We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
- 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
Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join!
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.
#LI remote
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Ergomeds fast-growing services business includes an industry-leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand and a full range of high-quality clinical research and trial management services under the Ergomed Clinical Research brand. ... View more
