The Company
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. As the world’s largest RCO (Research Consulting Organization), 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 Role
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.
Key responsibilities
* 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.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***