Director, Pharmacovigilance & Epidemiology
Stockley Park, United Kingdom | Major Biopharmaceuticals Company
Industry:Pharmaceutical / Biotech
Job Description:52 people have viewed this job
The Director within the department of Pharmacovigilance & Epidemiology (PVE)/ Epidemiology designs, directs, and executes observational studies, including pharmaco-epidemiological studies and non-interventional studies. The Director maintains a thorough knowledge of epidemiological principles, analysis methods and data resources as well as indications for their appropriate use. The Director leads interpretation of analysis results and leads 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.
Essential Duties and Job Functions:
Lead Epidemiology activities, design, direct and execute multiple observational studies to accomplish business objectives.
Develop and/or review protocols and Statistical Analysis Plans.
Oversee and/or actively contribute to the completion of 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 Epidemiology activities, including interaction with CROs, to accomplish business objectives.
Lead 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.
May lead internal and external educational initiatives.
Oversee and actively contribute to preparation and review of safety documents in response to regulatory authorities.
Provide epidemiologic expertise across the organisation throughout product lifecyle.
Oversee the review, synthesis, and critique of the literature.
Lead interpretation of analysis results, preparation of 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.
Lead intra-departmental and inter-departmental cross-functional project teams.
Lead 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, hiring and mentoring of direct reports, with responsibility for employee performance evaluations and professional development.
Knowledge, Experience and Skills:
High proficiency in the field of Epidemiology.
PhD epidemiology or related field and significant relevant experience.
Exceptional analytic, problem-solving, and critical thinking skills are required.
Experience in conducting observational studies and data analyses using real-world healthcare databases (e.g., non-interventional studies, electronic medical records, administrative healthcare claims, disease registries, national surveys, etc.) is strongly recommended.
Ability to work in a rapid, agile project style environment is required.
Proven effective written and verbal communication and interpersonal 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 or R is a plus.
Experience with using data visualization tools (e.g., Spotfire, Tableau) is a plus.
Knowledge of Microsoft Office, including Word, Excel, and PowerPoint is required