Experience
15 - 20 yrs
Job Location
Mumbai, India
Vacancy
1
Designation
Pharmacovigilance
Job Type
Not specified
Job Description
- 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 .
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