Around the world healthcare stakeholders are working to improve real-world patient outcomes through treatment innovations, care provision and access to healthcare. For the information, technology and service solutions they need to drive new insights and approaches, they count on QuintilesIMS. With a global team of 50,000, we harness insights, commercial and scientific depth, and executional expertise to empower clients to achieve some of their most important goals: Improving clinical, scientific and commercial results. Realizing the full potential of innovations. And, ultimately, driving healthcare forward.
Post: Pharmacovigilance for Experienced
Job Description
• To Prioritize and complete the assigned trainings on time.
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information; determining initial/update status of incoming events; database entry; coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
• Ensure to meet quality standards per project requirements.
• Ensure to meet productivity and delivery standards per project requirements.
• To ensure compliance to all project related processes and activities.
• Creating, maintaining and tracking cases as applicable to the project plan.
• Identify quality problems, if any, and bring them to the attention of a senior team member.
• To demonstrate problem solving capabilities.
• To mentor new teams members, if assigned by the Manager.
• Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
• Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Good understanding of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Standard Operating Procedures (SOPs) and work instructions applicable to the role
• Good knowledge of medical terminology
• Working knowledge of applicable Safety Database
• Knowledge of applicable global, regional, local clinical research regulatory requirements
• Excellent attention to detail and accuracy
• Good working knowledge of Microsoft Office and web-based applications
• Strong organizational skills and time management skills
• Strong verbal/written communication skills
• Self-motivated and flexible
• Ability to follow instructions/guidelines, utilize initiative and work independently
• Ability to multi-task, manage competing priorities and deadlines
• Ability to delegate to less experienced team members
• Willingness and aptitude to learn new skills across Safety service lines
• Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients
• Ability to work as a Team Player, contribute and work towards achieving Team goals
Qualifications
M pharm/Bpharm/BDS .
Experience in core PV (Drug Safety and Case Processing)-3 to 8 years only .
Kindly refer your friends .
Freshers need not apply
Additional Information:
Experience: 3-8 years
Location: Bangalore
Education: M pharm/Bpharm/BDS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 18th Nov, 2016
Please share your updated resume to my email id-roshini.y@quintiles.com
Posted by
Roshini
HRD, Quintiles
See All Quintiles Jobs B.Pharm Alerts M.Pharm Alerts Mumbai Alerts M.Sc Alerts
See All Other Jobs in our Database