During recent years, we have developed and structured a PharmacoEpidemiology (PE) and Real World Evidence (RWE) team, with high internal reputation and recognized external network, which is responsible of international PE/RWE studies. The department, as the scientific backbone of the Global RWE organization at Servier, is based at global R&D HQ and has quickly established a reputation for delivering valuable and pertinent strategic PE and RWE studies. The team works on Real World Data (RWD) studies with particular emphasis on field and database studies of medication safety including risk minimization evaluation (Post-Authorization Safety Studies) and also on a range of studies including epidemiologic knowledge for clinical development and comparative effectiveness for medical affairs and Market Access purposes across multiple therapeutic areas.
With an important number of drugs in development and planned launches in the following years, and the growing key roles of the RWE through the product life cycle, we are expanding the Pharmacoepidemiology & RWE Department. Recognized for our high level of expertise and experience in neuropsychiatry, cardiovascular diseases, rheumatology and diabetes, we now aim to develop the oncology field.
We are looking for a candidate with expertise and experience to provide leadership in PharmacoEpidemiology and Real World Evidence research in oncology. The role will involve internal and external collaborations; working with teams across Therapeutic, Regulatory, Safety, Medical Affairs and Market Access, as well as with external academics and CRO partners.
Actively contribute to define, for products in oncology, the RWE strategy and the RWD plans through the product life cycle
Design and conduct retrospective and prospective PE/RWE studies; including complex studies, many of them multi-database;
Define the methodology and write protocols;
Write or review statistical analysis plans and other study documents (recruitment plans,…);
Oversee the results, interpret and present the results;
Write and/or contribute to study reports and manuscripts;
Write and/or contribute to Agencies’ scientific documents;
Lead teams/projects with other internal and external research partners;
Scientific collaborations with international experts; participations in professional events and networks.
High academic record; ideally degree in Medicine, Pharmacy, Statistics or similar with post-training and advanced qualifications in pharmacoepidemiology
5 to 8 years of experience in the field of Pharmacoepidemiology; experience in oncology is required.
Beyond experience in PASS/PAES studies, prior experience with real word data to support clinical trials protocol design and/or for medical affairs/market access purposes is highly valued
Strong methodological skills; which should specifically include competency in designing comparative studies related to safety and risk minimization evaluation and/or effectiveness. Designs with secondary use of data sources (databases, chart review, …) is required.
Solid understanding of Pharmacoepidemiology guidelines and ENCePP practice and networks
Demonstrate effective communications skills in English (written, verbal and presentation) in multidisciplinary environment
Ability to establish and maintain effective working relationship with internal colleagues, teams and external partners/leaders
Internal Number: RF19
About LABORATOIRE SERVIER
Joining Servier means working in a stimulating environment and contributing to an innovative, research-based and people-oriented organization.
Servier is the leading French independent pharmaceutical company, located in 149 countries with 21700 employees and a turnover of about 4,152 billion euros in 2017.
Around 25% of Servier’s annual turnover is reinvested in Research & Development, reflecting the company’s dedication to its mission of innovation and discovery for improved treatment of unmet medical needs.
Organized as a foundation, we guarantee our independence from the stock exchange.
Servier is well known for its attention to the wellbeing of the staff, with particular importance placed on career evolution within the Group, and to an agreeable and productive working environment.