We work with biopharmaceutical and other Life Science companies with services and solutions that improve your probability of success, connecting insights with superior delivery for better outcomes. Quintiles' success begins and ends with your success. We share your goals and collaborate with you, bringing an industry recognized depth of expertise and breadth of perspective to shape better ideas. Our award-winning people, processes and technology drive predictable and efficient delivery around the globe. With more than 32,000 employees working in about 100 countries, we have helped develop or commercialize all of the top-100, best-selling drugs on the market in 2013. And it’s all done with an unwavering dedication to ethics and high quality, in the pursuit of success in human measures.
Job Title : Pharmacovigilance
Qualification : B.sc/M.Sc/B.Tech/M.Tech Bio-Chemistry/Bio-Technology / Microbiology
Experience : 2 - 7 years years
Job description :
- Receive and document incoming telephone calls or faxes from investigative sites or other sources reporting AEs, serious
- adverse events (SAEs) and spontaneous events; collect, track required data and enter into safety database, if applicable;
- follow up with sites to obtain missing data as required. Process data according to applicable regulations and guidelines,
- SOPs, and project requirements.
- Triage and classify incoming events; prioritze event case according to regulatory and project requirements.
- Ensure integrity and completeness of data according to applicable regulations and guidelines, SOPs and project-specific guidelines.
- Create complete, accurate and succinct narratives adhering to established project template. Establish and maintain a
- thorough understanding of project protocol, budget and scope of work (SOW) for assigned projects; set up and maintain
- project materials such as project files, forms, templates, databases and workflow.
- Establish and maintain effective project communications by representing department at interdepartmental project team
- meetings, investigator meetings, and client meetings and by conducting productive internal department project team
- meetings.
- Track financial status of assigned projects; assist Project Manager with clinical safety-related change orders.
- Provide regular reports to overall project manager and department management on project metrics, SOW changes, client
- requests or concerns; communicate and document project issues to project team members and department
- management in a timely manner; with guidance, complete regulatory reports.
- Mentor less experienced/new staff members
- All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES :
- Working knowledge of AE processing, CEVA and Post Marketing requirements
- Working knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical
- Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- In-depth knowledge of departmental SOPs
- Strong organizational skills with the ability to meet strict deadlines
- Skill in use of multiple safety databases
- Basic project management skills
- Demonstrate a positive and flexible working attitude
- Effective presentation and report writing skills
- Effective team building skills
- Effective telephone etiquette skills
- Excellent verbal and written communication skills
- Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
Apply Online :
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