Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Vacancy Details
- Department: Safety & Pharmacovigilance Coordinator
- Qualification:Any B Pharm , M. Pharm, Pharm D, graduates (2020/21/22 pass outs) with no backlogs or awaiting results. Preferably Pharm D and M. Pharm qualified students
- Experienced: 2020/21/22 pass outs
- Location: Gurgaon
Job responsibilities
• Monitors and routes incoming information to the appropriate project
• Records all ICSR documentation and tracks in accordance with Sponsor/customer specifications; distributes incoming mail and faxes.
• Redacts patient identifying information/ images in accordance with data protection guidelines, ICH GCP and GVP.
• Enters data into the safety database in accordance with Sponsor/customer specific guidelines and Company standards.
• Ensures current conventions are followed when entering cases into the Safety database.
• Performs file creation, tracking, retention, and maintenance (paper and electronic).
• Manages the translation process for any source documents requiring translation.
• Performs or assist with query follow up process as instructed
• Assists with submission processes as required
• Assists with daily workflow reconciliation
• Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process.
Qualifications
What we’re looking for
- Any B Pharm , M. Pharm, Pharm D, graduates (2020/21/22 pass outs) with no backlogs or awaiting results. Preferably Pharm D and M. Pharm qualified students
- Must have done Trainings / Certification in Pharmacovigilance
- Excellent Communication – Oral & Written
- Good proficiency in MS Office suite and have good typing skills
- Available to join immediately
- It is going to be office based opportunity, if applicant is looking for only Home based opportunities then they are not suitable for the positions
- Should have high speed internet at home to support office work without interruption
- Applicant Must be from Delhi / Gurgaon or Near by Cities . Ex: We are not going to consider applicants from Maharashtra/Hyderabad/Bangalore near by cities applicants and applying for Gurgaon location
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