- Part of the Project management team and oversees successful initiation, execution and completion of Pharmacovigilance project for Kinapse’ Global clients.
- Responsible for process implementation and ensure process compliance
- Managing project deliverables in line with the project plan
- Responsible for the training and mentoring of team members depending upon the project requirement.
- Responsible for work allocation, compilation and reporting of the project reports on timely basis.
- Undertake the QC activity for the tasks performed by other team members on an ongoing basis
- Develop and maintain quality control processes
- Act as a subject matter expert and help the team members with day-to-day trouble shooting activities.
- Create error-free reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to project management.
- Systematically review other Associate’s/SA’s/Physician’s work (both within own team, and in other PV Teams).
- Identifies and provides standards for gathering information for use in trend analysis and reports information to company management.
- Responsible for recruiting the right talent for the right job to ensure suitable headcount for project at all times.
- Responsible for the performance management of the team on an ongoing basis. This may include regular interaction with team members, identify the areas of improvement and implement a subsequent training or mentoring plan to ensure all the team members meet or exceed targets with highest level of employee satisfaction.
- Interact with client on a regular basis to understand the client’s requirement for a particular project and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints.
- Keeps a vigilant eye on changing processes in industry and suggests areas for improvement in internal processes along with possible solutions.
- Communicates effectively with internal clients to identify needs and evaluate alternative business solutions
- Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.
- Responsible for creating or updating the SOPs, WINs as per project specific requirements
- A minimum of a Bachelor’s degree in scientific domain (B-Pharm & M-Pharm, Ph. D or Post Graduate in Life Sciences, MBBS or BDS or BHMS or BAMS).
- A minimum of 7-8 years Pharmacovigilance industry experience within a pharmaceutical company or at a CRO
- Experience of managing teams in Pharmacovigilance domain would be preferential
- Good understanding of clinical development processes including principles of clinical study operations, and ICH-GCP guidelines.
- PV writing experience is a must
- Excellent written and verbal communication skills, including presentation to cross-functional teams
- Strong MS Word/ PowerPoint/ Excel knowledge
- Ability to manage time by planning and prioritising deliverables.
- Analytical capabilities, proficiency and comfort with the analysis of complex scientific data set.
- Commitment to highest quality outputs, including obsessive attention to detail
- Ability to be a successful team collaborator, but also self-motivated and able to work independently
- Enthusiasm and pro-activity
- Knowledge of applicable global and regional regulatory requirements
Kinapse is a fast-growing, values driven company with a supportive team and can offer you a rewarding and challenging career working with smart, ambitious, yet humble professionals. We offer a mixture of both office and home working, and a competitive salary with a range of benefits.
If you want to be part of a progressive, forward-thinking company and want to make a difference we would really like to hear from you!