Senior Manager, Pharmacovigilance & Epidemiology
A leading biopharmaceutical organisation with a solid commercial portfolio of life-saving drugs within a number of therapy areas have a new Senior Manager, job opportunity at their offices in Uxbridge. The company has a growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents.
The Senior Manager within the department of Pharmacovigilance & Epidemiology (PVE)/Epidemiology designs, directs, and executes observational studies, including pharmaco-epidemiological studies and non-interventional studies.
The Senior Manager maintains a thorough knowledge of epidemiological principles, analysis methods and data resources as well as indications for their appropriate use. The Senior Manager contributes to and may lead interpretation of analysis results and preparation of study reports, conference abstracts, presentations and manuscripts.
The successful candidate will also demonstrate a thorough knowledge of statistical programming principles, analysis methods and data resources, as well as indications for their appropriate use.
- Lead Epidemiology activities, design, direct and execute observational studies to accomplish business objectives.
- Develop and/or review protocols and Statistical Analysis Plans.
- Oversee and/or actively contribute to the completion of all analytical/validation activities for studies/projects, in collaboration with Epidemiology Programming.
- Oversee and/or actively contribute to analysis/validation projects utilizing industry-standard analytic tools.
- Lead and/or support Epidemiology activities, including interaction with CROs, to accomplish business objectives.
- Participate in special projects based on extensive knowledge base, experience and competency.
- Provide epidemiologic input into Pharmacovigilance Plans, and may contribute to Risk Evaluation and Mitigation Strategy programs.
- Contribute to and may lead internal and external educational initiatives.
- Contribute to preparation and review of safety documents in response to regulatory authorities.
- Provide epidemiologic expertise.
- Review, synthesize, and critique the literature.
- Prepare study reports, conference abstracts, presentations and manuscripts.
- Identify, assess, and integrate/implement new data resources, methods, technology and analytic tools.
- Actively contribute to identification and assessment of safety signals and trends using active surveillance methods.
- Participate in and may lead intra-departmental and inter-departmental cross-functional project teams.
- Participate in process improvement initiatives, including SOP/WRK updates and audits.
- Demonstrate excellent attention to detail, teamwork and initiative, with flexibility to adapt to the needs of the organization; maintain meticulous attention to project deadlines.
- Successfully interacts with other groups within PVE.
- Mentor junior departmental staff to ensure competence in epidemiologic skills and knowledge.
- May participate in recruitment and hiring of personnel.
Skills and Requirements:
- High proficiency in the field of Epidemiology.
- PhD or MPH/MS in epidemiology or related field.
- Exceptional analytic, problem-solving, and critical thinking skills are required.
- Ability to build and maintain complex and efficient SAS routines, using SQL, macros, and multi-processing techniques.
- Ability to write and run code in Stata.
- Ability to write and run code in Teradata and/or R is a plus.
- Excellent written and verbal communication and interpersonal skills are required.
- Ability to work in a rapid, agile project style environment is required.
- Knowledge of Microsoft Office, including Word, Excel, and Powerpoint is required.
- Pharmaceutical industry and/or CRO experience is a plus.
- Previous contract in a research institution or academic institution is a plus.
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 call Kelechi Dyke on +44 203 854 0200 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.