Job Details:
ROLE : Global Head of PV
A pharmaceutical company developing and selling generic and biofactor products are seeking a candidate for the HQ in SW Germany. This is a great opportunity for those in a deputy EU-QPPV role and looking for a step up or those already in this role and seeking a new challenge within family-run company.
INDUSTRY : PHARMACEUTICAL
LOCATION : BADEN-WUERTTEMBERG
SALARY RANGE : TO BE DISCUSSED
RESPONSIBILITIES :
- Promote, maintain and improve compliance with internal and legal requirements regarding pharmacovigilance
- Submission of all PV-relevant documents in accordance with statutory provisions and GVP guidelines
- Central contact point for the responsible authorities
- Development, continuous improvement and adaptation of the global PV system, the PSMF and the PV-related SOPs
- Dealing with pv-relevant product complaints
- Monitoring drug safety profiles and emerging safety concerns
- Monitoring of risk mitigation measures and control of risk management plans
- Review and approval of study protocols in clinical research
- Leadership and development of the team at headquarters and the employees of the Global Pharmacovigilance Network
- Support of affiliated companies, local representatives and cooperation partners in PV matters, including training of PV employees
- Function as EU-QPPV and "phased plan officer" in Germany
REQUIREMENTS :
- Successfully completed (preferably) medical or pharmacy studies
- Extensive experience and understanding of pharmacological, pharmaceutical and pharmacovigilance related topics
- Knowledge of the applicable legal requirements and relevant legislation
- Strong leadership, communication and presentation skills as well as structured and precise work
- Ability to prioritize projects, strong sense of urgency and excellent problem-solving skills
- Flexible mind-set, reliable team player and a high degree of loyalty
- Fluent written and spoken English
- Good computer skills (Microsoft Office and database applications)
If this sounds like a good match for your profile, apply now and your application will always be followed up with a response. If you are looking for something new but this isn''t quite right for you, then get in touch for a confidential consultation:
Email: R.Martin@nonstop-recruitment.com
Phone: +49 892 109 3363
Internal Extension: 3490
Raymond Martin is a recruiter and head-hunter with a focus on the German Regulatory Affairs Market. He assists candidates and clients alike with recruitment related topics.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover