about 3 years ago
Pharma-Partners is working closely with an established yet still rapidly growing biotechnology business to help with growth in the Global drug safety function. This patient-focused business offers a fast-paced and commercially challenging environment, with the pharmacovigilance team being truly engaged with the wider business in delivering critical product safety analysis and benefit-risk assessments.
The global safety team is based in the US and the UK, and this role works in part of the team located in the UK offices led by an inspirational and experienced Senior PV Director. There is a lot of responsibility to be had in this role and team, and you would certainly have a high profile within the business when interacting with colleagues in medical, regulatory and clinical operations. This safety team is close-knit and beyond your day-to-day duties there is excellent scope to be mentored by other senior physicians who sit between you and the Senior Director.
- Implementation of the strategic safety plan for assigned products at a global level
- Involvement in regular product related safety and benefit-risk assessment meetings with the wider business (medical, regulatory etc)
- Interface with external stakeholders such as regulatory authorities (FDA, MHRA, EMA) where required in relation to product safety issues and product filing
- Input in to protocol design and implementation for post-authorisation safety studies in particular across Europe, working closely with colleagues to develop safety aspects of clinical study reporting (CSRs) and related activities
- Medically qualified (MBBS, MBChB, MD or equivalent)
- Significant post-qualification clinical experience in the NHS or equivalent
- Pharmacovigilance experience in the pharmaceutical industry, ideally over a number of years preferably in a global role
- Understanding of local, regional and global regulations for developmental and marketed drugs
- Confident and courageous in terms of taking the lead on projects, and building relationships with internal stakeholders that sit in commercially driven teams
- Ambition to take on more responsibility as you grow, and become a leader
- First rate communication skills i.e. being able to communicate effectively with people at different levels across different teams
To apply for this position please use the “Apply” option or feel free to send your CV directly to the Pharma-Partners team via email email@example.com