We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. 

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. 

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives. 

PrimeVIgilance are looking for a Senior Director, ICSR to be based in Pune, Mumbai or Bangalore.

Manages ICSR Management Unit and ensures all unit-relevant activities are delivered within agreed extent. Contributes to achieving company´s goals and objectives. Performs project budget reviews, management of the ICSR Management Unit and its ICSR Operational Leads. Other responsibilities include independent analysis of workload, productivity and utilization of resources and their appropriate redistribution to ensure performance of the highest quality as well as coordination with other departments for all activities related to the ICSR Management Unit. 

Role and Responsibilities 

• Managing the ICSR Management Unit effectively 

• Ensuring adequate resources within the ICSR project teams to achieve the maximum level of productivity and utilisation 

• Setting productivity targets for ongoing projects and reviewing proposed target updates as required 

• Based on reports and analyses, defining the appropriate reallocation of resources in ICSR Management Unit, or working with the resourcing unit for reallocation to and from other units and departments 

• Managing ICSR Operational Leads to ensure all employees are adequately utilised and productive and reallocating employees to other ICSR Operational Leads teams if necessary 

• Notifying the Resourcing department about the need for additional resources for assigned project teams if resources cannot be managed internally and officially opening the requests upon approval and budget confirmations 

• Proposing the necessary changes within the project team processes to Safety Data Management Department Head 

• Finding solutions and introducing best practices to increase productivity and utilization within the ICSR Management Unit 

• Training and mentoring of ICSR Operational Leads  

• Preparing various analyses and reports 

• Reviewing budgets and resource allocations for all new projects and new scope of work for existing projects and supporting Directors of Projects, as applicable 

• Supporting the Business/Commercial team during development of contracts and proposals, as applicable 

• Supporting the Operations and Project Analytics team, as applicable 

• Assisting HR in employee recruitment, performance evaluation, promotion, retention and termination activities 

• Reviewing and approving all Critical CAPAs from the ICSR Management Unit 

• Reviewing and addressing any requests from Quality department regarding ICSR Management Unit 

• Reviewing and updating PrimeVigilance operating procedures and guidelines, as applicable 

• Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager 

• Life science graduate, pharmacy, nursing, other healthcare related qualification
• Extensive work experience in pharmacovigilance plus demonstrated experience in a leadership position with line management responsibilities.
• Excellent communication (written and verbal) skills 
• Excellent organization skills, including attention to details and multitasking 
• Excellent management skills, including delegation skills, time and issue management 
• Technical skills 

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We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.  

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

We offer: 

• Training and career development opportunities internally  
• Strong emphasis on personal and professional growth 
• Friendly, supportive working environment 
• Opportunity to work with colleagues based all over the world, with English as the company language 

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!  

• Quality 
• Integrity & Trust  
• Drive & Passion  
• Agility & Responsiveness  
• Belonging 
• Collaborative Partnerships  

We look forward to welcoming your application.