Hendre Moolman at CK Clinical is currently recruiting for a Risk Management Scientist to join a global pharmaceutical at their site in Berkshire.
As Risk Management Scientist you will be responsible for the following:
- review and analysis of safety data, development of routine and ad hoc safety/risk assessment reports and preparation of Risk Management Plans and Risk Evaluation and Mitigation Strategies.
- the quality and technical content of prepared reports and making sure that they are approved by appropriate functions and meet deadlines for regulatory submission.
- Demonstrate knowledge of relevant global regulatory requirements and practices
- Act as subject matter expert in the development and maintenance of the Safety Quality System and training tools/programs as they relate to epidemiology
- Provide pharmacoepidemiology support to GPS Surveillance Teams
- Understand the roles and responsibility of the EU QPPV. Support audit readiness
- Provide epidemiology expertise to support compounds in development, new product launches, and existing marketed products
- Partner/collaborate with both EPM/Transition/GBD Teams and GPS TA physicians on the development of risk management plans
- Lead / contribute to the design, execution, and assessment of specialised risk minimisation activities
- Design, conduct, and manage pharmacoepidemiology studies
- Work with external investigators and CROs
- Review and develop study protocols; use population-based health statistics and electronic health information databases in evaluating safety issues
- Provide support to EPM/Transition/GBD Teams and GPS TA physicians with patient population data from the literature or other relevant data sources to understand the nature and burden of illness of various disease/conditions for which the Company is developing new products to treat or to prevent
- Conduct and manage epidemiology studies to characterise disease trends, frequencies, incidence/prevalence, co-morbidities, outcomes, risk factors and treatments
- Communicate effectively with relevant internal business partners
- Collaborate with EPM/Transition/GBD Teams and Regulatory Scientists as part of issue management teams and in preparation of responses to requests posed by regulatory authorities;
- Support EPM/Transition/GBD Teams regarding safety information requests and other safety activities
- Collaborate with external partners and participate on key external initiatives.
- Develop analytic tools to support activities such as disease state characterisation, signal detection, clarification, and evaluation utilising multiple data sources
- Partner on the development of new standardised analytic methods for selected regulatory safety documents/submissions (e.g., PSUR, ISS, product labels)
- The role may also entail line supervisory or contract-employee responsibilities for a small group of Epidemiologists, including implementation of organisational objectives, putting in place and ensuring execution of performance management and development plans
- The supervisory responsibilities may require up to 25-30% of the epidemiologist’s time; the remaining 70-75% will focus on direct product support and technical/scientific activities.
Qualifications, Skills and Experience:
To be considered for this Risk Management Scientist position, you will have the following qualifications, skills and experience:
- A PhD or DrPH in epidemiology or other subject with high epidemiologic content.
- Applicant must have at least 1-2 years relevant research experience in a pharmaceutical company or CRO as a pharmacoepidemiologist/epidemiologist.
- Ability to conduct epidemiology research including preparation of study protocols and statistical analysis plans.
- Competent in the independent analysis of data from clinical and epidemiology studies.
- Excellent computer skills; knowledge of SAS, SPSS, Epi Info, and/or equivalent statistical software package.
- Have strong analytic skills, oral and written communication skills, strong interpersonal and leadership skills, and be able to work independently and as a team member to resolve a variety of drug safety issues
– Clinical background (e.g., PharmD, MD, RN)
– High-level knowledge of global regulations with respect to drug safety and adverse event reporting
– High-level knowledge and good understanding of GPS policies
How to apply:
For more information or to apply for this Risk Management Scientist position, please contact Hendre at CK Clinical on 01438 870 023 or email firstname.lastname@example.org. Please quote reference CL22705 in all correspondence.