Syneos Health looking for Safety & Pharmacovigilance Coordinator
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.
Post : Safety & Pharmacovigilance Coordinator
Job Description :
• 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.
• 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
Qualification : B.Pharm , M.Pharm, PharmD
Location : India-Asia Pacific – IND-Gurugram-Cyber-City
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Pharmacovigilance
End Date : 30th November, 2022
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