Who are Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time.
We are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented.
We believe that challenging something is the best way to change it.
We are looking future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines : the best available treatment at an affordable price.
That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
ROLE PURPOSE :
Overall LSO responsibilities for both countries according to the SLA between GMS and Jansen Pharma Company / J&J Consumer Company and OCMS (UK and Ireland)
PRINCIPAL RESPONSIBILITIES :
You will be ensuring management of the LOC product activities in compliance with local regulations and company policies / procedures at a local, regional and global level and in accordance with any product vigilance agreements with third party business partners.
You have an appropriate system of pharmacovigilance and consumer product vigilance and Risk Management in place in order to assure appropriate oversight for products within its responsibility.
The CSTL will ensure that Safety maintains connected with the all relevant business partners.
Line Management Responsibilities : Managing and mentoring local safety staff on local level.
You will be responsible for the LOC PV related decisions.
Issues should be advanced according to compliance procedures and resolutions cooperated with partners.
Describe where this position fits in relation to the rest of the department it resides.
You have a reporting line into the Vice President, Qualified Person Pharmacovigilance and International Pharmacovigilance via the Area Safety Lead (ASL) and Cross Sector EMEA Safety Head.
You will have line management responsibility for 28 employees within the team.
EDUCATION & EXPERIENCE REQUIREMENTS :
Does your have experience of leading a team? And :
You are Degree qualified ideally in life sciences.
You have sound knowledge of general medicine or pharmacy and clinical practice, or meaningful scientific / medical field.
You have the ability to organise workflow activities and manage multiple critical issues.
You are aware of and familiarity with industry principles of product vigilance, drug development and pharmacology.
Expert knowledge of Global, Regional and Local Procedural Documents as applicable.
You have excellent verbal and written interpersonal skills with an ability to negotiate and communicate with internal and external customers.
Ability to establish and maintain open relationships within the organization and with authorities.
Demonstrable knowledge of all local requirements and of global aspects of product safety.
Medical or pharmaceutical sciences by preference, with expertise and experience in pharmaceutical regulations and R&D processes.
By preference a minimum of 2 + years pharmaceutical industry experience with at least 1 year in a product vigilance responsibility role.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.