General Manager- Pharmacovigilance

Job highlights

• . Education: Graduate / Post Graduate/ Doctorate degree in life sciences / Pharmacy/Medical sciences or equivalent degrees .

• Minimum Work Experience Required: 15 years with minimum 8 years of Project Management exposure in BP environment or experience in a Contract Research Organization or pharmaceutical company . .

• Individuals in this role are responsible for end to end delivery of project/s, while ensuring client satisfaction business growth & profitability

• Coordinating, managing and monitoring the medical, safety, regulatory, operational and/or quality aspects of Pharmacovigilance to ensure the smooth running of the project/s and the achievement of the business unit s yearly goals.

• Provide input regarding the global coordination and development of Pharmacovigilance.

• Assist with overseeing department and project finances.

• Identifying failure points which impact business & customer and suggest preventive & corrective measures

• Analyze operational risks Failure Mode Effective Analysis (FMEA), extend support in managing client escalations Root Cause Analysis/ Corrective Action Preventive Action (RCA/CAPA) and work across traditional functional boundaries to mitigate risks and establish common goals to deliver value to the business.

• Act as a Change Agent and ensure good collaboration with Quality, Transition, Training, On-site teams and Clients to optimize Quality, Efficiency, Cost and Customer Value in multiple client engagements.

• Ensure the agreed SLA s are met as per SOW

• Understand Client s core objectives, ensure that all driven timelines are met, identify key program requirements through a structured design and implementation process, and ensure that these requirements and any new requirements specified by Client are met.

• Analyze current situation (As-is), identify improvement opportunities and recommend measures (To-be) to re-engineer processes

• Understand the content of all SOPs.

• Identify process re-engineering and automation opportunities to reduce manual interventions

• Implement Quality standards to achieve process excellence

• Communicate and collaborate with internal stakeholders and customers (both at onsite and off-shore) to understand their pain areas working to apply their insights to challenge and modify current approaches/ways of doing things.

• Education: Graduate/Post Graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees

• Minimum Work Experience Required: 15 years with minimum 8 years of Project Management exposure in BP environment or experience in a Contract Research Organization or pharmaceutical company .