For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Senior Pharmacovigilance Consultant implements and maintains QPPV office services for ProPharma Group clients such as EU Qualified Person responsible for Pharmacovigilance (QPPV), Local Person responsible for Pharmacovigilance (LPPV), maintenance of Pharmacovigilance System Master Files (PSMF) and regulatory intelligence (RI). The Senior PV Consultant serves as a Subject Matter Expert (SME) for assigned PV areas.
Accounts for the implementation of global and local PV services for clients and oversees successful service delivery from operational perspective.
Assumes positions for clients as needed including the QPPV or the LPPV which may include the Graduated Plan Officer in Germany.
Where required, takes responsibility for and leads:
Creation and maintenance of Pharmacovigilance System Master File
(Pharmaco-)Vigilance advice on medicinal products and medical devices
Management of activities related to clinical trials, e.g. serve as the Responsible Person
Regulatory intelligence review and compliance for clients and ProPharma Group
Implementation and evaluation of local literature searches
Preparation and negotiation of Pharmacovigilance Agreements/Safety Data Exchange Agreements, if not delegated to the Alliance Management team
Oversees PV Alliance Partners performing activities on behalf of ProPharma Group, if not delegated to the Alliance Management team.
Provides feedback and updates to the current QMS documentation relevant for the QPPV office process including client specific Working Practices and associated Work Instructions.
Develops and delivers PV training.
Supports client audits and inspections.
Experience and skills required
University Degree (BSc EQF level 6, MSc EQF level 7, or PhD EQF level 8), in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, nursing, life science, medical technology or biology.
Minimum of 4 years’ experience in clinical and/or post-marketing pharmacovigilance
Strong knowledge of EU PV legislation and guidance.
Fluent in German and English
Strong stakeholder management skills
Can perform multiple projects at once
Pro-active approach & strong interpersonal skills
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***