Job ID : 234186BR
Name of the Post : Senior Pharmacovigilance Process Manager
Division : Global Drug Development
Business Unit : CMO & PATIENT SAFETY GDD
Work Location : Hyderabad
Functional Area : Research & Development
Job Description :
Lead assigned complex cross functional and CMO&PS projects, including IT projects/systems, which are of a high priority / criticality to the business. Assembling the appropriate teams and supervising/directing their work.
Act as the functional lead for multiple pharmacovigilance processes by:
• Leading the review of emerging worldwide regulations, performing impact assessments and driving process changes required to ensure ongoing compliance to global regulatory requirements.
• Leading the development and maintenance of procedural documents by process owners
• Developing training and communication strategies and overseeing the production and maintenance of documents by process owners
• Establishing clear processes for tracking regulatory compliance as well as compliance to internal requirements and, in the case of any delays, ensuring investigation in to the root cause and implementation of corrective and preventative actions (CAPAs) is performed and the effectiveness of the actions measured.
• Driving continuous process optimization and simplification
• Collaborate with other Pharmacovigilance Process Leads to ensure alignment and con-sistency between processes and maximize efficiency
• Providing periodic updates to Functional Manager on activities and ensuring appropriate and timely escalation of issues
• Supporting Pharmacovigilance Process Excellence management with developing and im-plementing group operational strategy including outsourcing strategies and objectives
Act as process owner for one or more assigned higher complexity pharmacovigilance process within their functional area by:
• Authoring procedural documents
• Developing and maintaining training material and communications
• Analyzing the impact of other process and organizational changes
• Work in collaboration with the Compliance & Quality function to produce compliance re-ports and complete quality checks to monitor regulatory compliance as well as compli-ance to internal requirements. In the case of any delays, investigate the root cause and develop and implement CAPAs. Measure effectiveness of actions taken.
• Resolving queries from other functions and Country Organizations (COs) and acting as a consultant to CMO&PS associates and other global line functions on regulatory require-ments
. Act as a subject matter expert during audits and inspections (e.g. EMA, FDA) and lead the preparation of responses to findings and the development and implementation of CAPAs
• Representing Novartis externally as a subject matter expert
Work jointly with Compliance & Quality and Process Compliance & Risk Mitigation functions to perform metrics trend analyses, generate knowledge and mitigate any identified risks.
Collaborate with other Global Line Functions across Novartis Divisions and Third Parties to meet joint accountabilities.
Deputize for Functional Manager and assist with the recruitment of new staff.
Minimum Requirements –
- PharmD, MSc degree in life sciences or equivalent.
- Languages: Fluency in English. Knowledge of other languages desirable.
• Minimum 7 years of experience in the pharmaceutical industry, particularly Pharmacovigilance.
• Leadership and (matrix) management experience.
• Ability to lead and deliver cross-functional initiatives in a matrix environment.
• Strong organizational and project management skills.
• Strong negotiation and communication skills and ability to operate effectively in an international, matrix environ-ment
• Ability to lead global and cross-functional work groups; deal and interact with a wide variety of people at all levels.
• Experience of working with and supporting a team; ability to coach and mentor.