Pv Literature Surveillance Quality Expert

Provide oversight and support to vendors to ensure productivity and quality of all activities
- Maintain technical and global regulatory expertise
- Ensure adequacy of training on different topics: Database, SOP, and knowledge in pharmacovigilance field, library and clinical development in order to improve flexibility, professionalism of all resources
- Ensure compliance with regulations and with CHC SOPs and working practices
- Ensure timely and appropriate fulfillment of all activities
- Serve as global literature SME in support of affiliates

2. Management of Literature Surveillance Operation:

- Oversee Literature Surveillance resources with regards to literature surveillance activities and ensure adequate resource allocation
- Plan, organize resources following the business needs for the supported processes, including coordination with technology platform team
- Inform literature lead about any timeline deviation and resource needs
- Ensure high quality of literature retrieval and triage for safety surveillance and case management

3. Internal / External Communication:

- Foster and supervise effective interaction and communication between the Literature Surveillance support resources and internal/external providers/customers
- Communication with other functions within GPV especially Case Management, Safety Surveillance and Risk Management, Periodic Reporting and System Systems and Data Management
- Communication and coordination with client group departments across entities and globally
- Participation in working groups as needed
- Ensure transparent communication to literature lead to ensure efficient decision-making process
- Serve as Literature Surveillance SME at Audits and Inspections

Skills and Education:
**Education**:

- Pharm.D. or Bachelor’s Degree in Health Science or related field (e.g. pharmacy or nursing) preferred with minimum 3 to 5 years total experience in international pharmacovigilance for both marketed products and/or projects under clinical development
- Previous experience surveilling and assessing literature for safety or broader medical purposes
- Working knowledge of worldwide pre and post marketing safety reporting regulations and requirements including ICH guidelines

Required knowledge and/or experience:

- Ability to work in a global, multi-entity, multi-cultural environment across time zones
- Excellent English communication skills, both verbal and written
- Excellent teamwork and collaboration skills
- Pharmaceutical industry experience, especially in pharmacovigilance
- Knowledgeable in areas of ICSR, signal/risk management, and periodic safety reporting especially as related to literature surveillance
- Capability to organize and effectively multitask/prioritize activities
- Computer literacy especially in Windows based programs
- Ability to solve problems, to take initiative, to meet challenges, negotiation skills
- Excellent written and oral communication skills
- Ability to effectively work with others throughout the organization
- Ability to accurately and effectively communicate the literature surveillance process in an audit/inspection
- Adaptable/Forward thinker with continuous process improvement always in mind

Cultural traits / P2W Behaviors:

- Push to go beyond the level we have operated until now: constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment
- Put the interest of the organization ahead of own of those of his/her team: consider both short and long term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level
- Act in the interest of our patients and customers: actively engage with customers to know their current and future needs; brings an external perspective into decisions
- Take action and don’t wait to be told what to do: take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others’ advice to make bold and impactful decisions which move us forward
- Role model our 4 values: teamwork, integrity, respect, courage

Language skills
- Fluent spoken and written English
- Cultural traits / P2W Behavior
- Push to go beyond the level we have operated until now: constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment
- Put the interest of the organization ahead of own of those of his/her team: consider both short and long term impact of decisions; puts collective and global goals above individual or loca