An exciting opportunity is now available for a Pharmacovigilance Operations Manager position within Global Medical Safety in Buckinghamshire, UK.
You will be responsible for the direction and supervision of operational and management activities for a team of Safety Associates responsible for single case processing of adverse event report cases. The position will report to the Director of Pharmacovigilance Operations GMS (Global Medical Safety).
- Management of assigned team in their daily activities to ensure timely and accurate completion of tasks;
- Monitoring of team workload and resource needs/allocations;
- Expertise in and application of operations activities including single case processing;
- Collaboration with other GMS functions to develop unified consistent processes to meet standards and ensure regulatory compliance;
- Collaboration with other departments to clarify procedures and ensure compliance;
- Evaluation and identification of staff training needs to ensure all personnel are trained and adhere to Departmental SOPs, guidelines and standards to ensure compliance with regulations and policies;
- Participation in local/international multidisciplinary teams;
- Provision of guidance to direct reports on performance development, including setting goals and objectives, and conducting performance review meetings;
- Participation in recruitment of new staff.
- In addition, an Operations Manager may support the Director/Senior Director in audits or inspections, you will have the opportunity to be part of the management team for Operations and may act as a back-up for the Director.
Qualifications & Experience:
- Bachelor’s Degree or higher degree in Health/Biomedical Sciences and/or previous experience in a management role in a relevant discipline.
- Extensive knowledge and experience in safety processing, regulatory compliance, clinical study and spontaneous safety reporting.
- Knowledge of global safety reporting/regulations in the pharmaceutical industry
- People management experience.
- Experience in high volume work environment and experience with multinational/multi-company integration activities would be preferred.
- Strong leadership skills, plus the ability to thrive in a global matrix environment and facilitate on-going change.
- Strong administrative and supervisory/management skills with substantial experience in pharmaceutical safety areas and should also have experience in staff recruitment.
- Ability to coordinate workflow activities for their assigned team, with the ability to allocate resources and to evaluate operations and procedures against outcomes to identify methods for process/compliance improvement.
- Ability to work independently using initiative and autonomy in achieving objectives, and to be involved in multidisciplinary interactions and coordination including compliance audits.
- Ability to organise training activities and to train personnel regarding pharmaceutical safety topics.
- Excellent verbal and written communication skills, plus good computer skills including a working knowledge of computer applications such as word processing, electronic mail and safety systems.
For more information or to apply for this Pharmacovigilance Operations Manager position, please contact Hendre Moolman at CK Clinical on +44 (0)1438 743047 or email firstname.lastname@example.org quoting 21083 to indicate your interest.