The Associate Manager PV Operations will manage and supervise project’s PV Operations staff on a day-to-day basis, guiding performance of PV Operations staff in ongoing projects in terms of quality of deliverables, compliance with the timelines and relevant trainings and update his/her Line Manager. He/she will also provide process-related expertise for the various project specific activities including but not limited to processing of Individual Case Safety Reports, Signal and risk management, Regulatory operations and Medical writing, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs) and communicate with his/her Line manager/client for queries/feedback as needed.
- Delegate work to PV Operations staff according to
- allocated budget/hours
- Ensure that the work provided by the PV Operations staff is in accordance with the hourly budget provided by Solutions Consultant
- Organize, in conjunction with local quality and training staff, mentoring and training (general and on-the-job) for new staff and ensure continuous training within the department and with other departments, where appropriate
- Perform annual appraisals of PV Operations staff, and provide recommendations for promotions, career development, and identify and resolve employee issues potentially impacting project performance and team spirit
- Maintaining awareness of any performance issues within the team and updating his/her line manager
- Ensuring communication of important decisions/policies discussed with senior management or the client to the team
- Ensuring to meet the requirements as in Service Level Agreements and achieving all defined and agreed Key Performance Indicators in terms of quality, compliance and trainings
- Providing functional expertise/oversight of process and handling queries of the PV Operations staff
- Participation in meetings with client and within team, as needed.
- Performing activities delegated to the PV Operations staff in case of unplanned peaks or urgent requirements.
- Prepare for and respond to internal/external audits/inspections.
- Providing updates to his/her line manager on frequent/as needed basis
- Assisting his/her Line manager for operational day-to-day activities
- Maintaining up-to-date knowledge of relevant regulations and client’s
and Parexel’s Standard Operating Procedures
- Inculcating leadership and professional skills in the team
- Excellent leadership and line management skills
- Excellent knowledge of drug safety and the drug development process
- Excellent knowledge of and ability to interpret and apply global safety regulations
- Experience in data analysis, evaluation of safety data and the preparation of safety reports • Excellent team / project leadership and delegation skills
- Ability to train and mentor people
- Excellent presentation skills
- Excellent interpersonal skills
- Excellent verbal / written communication skills
- Excellent time management skills
- Client focused approach to work
- Experience with computer applications including database management and Pharmacovigilance related computing systems