Senior Pharmacovigilance Scientist (Vendor Management)
An international pharmaceutical company is advertising a vacancy for a Senior Pharmacovigilance Scientist (Vendor Management) at their office in At Alban. The company supplies medicines and medical devices across Europe and the US, making partners across 60 countries worldwide in the meantime. This is an exciting opportunity to work with and provide real expertise to a rapidly growing speciality pharmaceutical organisation.
- Supporting the review of pre - and post - marketed product safety data during the product's life cycle.
- Managing and reviewing of internal and external processes, auditing procedures and partner agreements (SDEA and PVA), as well as ensuring robust reporting and tracking is in place.
- Supporting the Global PV manager to ensure that Adverse event reports are processed in an accurate and timely manner.
- Working with the Global PV Manager to prepare for internal and external audits.
- Ensuring that company's personnel are trained on PV during the induction to the company and that retraining is carried out on an annual basis.
- Working closely with all internal departments, particularly Quality Assurance, Regulatory and the wider medical team.
- Keeping up to date on PV best practice and share knowledge and learning with the team.
- Establishing a strong working relationship with company's 3rd party PV provider(s), ensuring consistent and timely communications daily.
- Participating in weekly one to one meeting with company's QPPV. These meetings will include discussion on all aspects of PV management including ongoing CAPAs, SDA updates, PMSF updates and PSUR/RMP updates.
- Responding to queries on medical information, working closely with the internal medical team to provide timely and accurate responses.
- Obtaining full information from the vendor regarding any product complaints.
- Liaising with the Quality Assurance team to ensure the complaints are resolved fully and in line with internal procedures and SOPs.
- Liaising with the PV vendor to ensure regulatory compliance is to a high level.
- Supporting the PV provider with the production of PSUR's and other documentation.
- Investigating data received from the partners by the PV Vendor, contacting the partner to ascertain the nature of the data and provide feedback as required.
- Supporting the Global PV Manager during negotiations relating to PV when implementing or renewing Partner contracts.
- Providing solutions to overcome challenges
- Taking opportunities and make quick but measured decisions, seeking the input of others where necessary.
- Striving to be the best, taking own initiative to create opportunities for learning and developing.
- Putting the customer and patients at the heart of everything you do.
- Constantly displays a passion for delivering and striving to exceed.
- Seeking feedback on a regular basis from others to measure progress of plans
- Analysing highly sensitive and complex data to generate potential solutions.
- Consulting others during various phases of the problem-solving process.
- Mobilising others during various phases of the problem-solving process.
- Demonstrating creative and innovative thinking to find best solutions.
- Modelling creative and innovative thinking to find best solutions.
- Receiving information to seek and understand differing perspectives.
- Actively seeks perspectives from others to ensure inclusiveness and understanding.
- Using interpersonal skills to build cooperative relationships.
- Tailoring and presenting information to diverse audiences using a variety of communication delivery methods (e.g., written, electronic, oral, interpersonal).
- Maintaining an understanding of company's working practices and SOPs and relevant country codes and ensuring these standards are met across the organisation.
- Able to review medical writing and source document.
- Ability to adhere to written procedures, guidelines and legal requirements.
- Knowledge of the drug development process.
Skills and Requirement:
- BSc or equivalent Life Science degree.
Excellent written and verbal communication skills.
- Knowledge of common data processing software.
- Good interpersonal skills, including communication, collaboration, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, strategic thinking, manages complexity, punctuality, and collaboration in a team environment.
- Good IT skills including experience of using programming languages and data analysis software packages.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kevin Hansberry at 0207 440 0636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.