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 - Trainee (Contractual | M.Pharm/Pharm.D/BHMS/BDS | 2025 Passout only)
Job Responsibilities
• Monitors and routes incoming information to the appropriate project if required.
• Records all ICSR documentation and tracks in accordance with Sponsor/customer specifications; distributes incoming mail and faxes if required.
• Redacts patient identifying information/ images in accordance with data protection guidelines, ICH GCP and GVP if required.
• May enter data or assist in the creation of cases into the safety database in accordance with Sponsor/customer specific guidelines and Company standards if required.
• Ensures current conventions are followed when entering cases into the Safety database.
• May perform file creation, tracking, retention, and maintenance (paper and electronic).
• Manages the translation process for any source documents requiring translation if required.
• Performs or assist with query follow up process as instructed.
• Assists with submission processes as required.
• May assist with daily workflow reconciliation.
• Assists with global or local safety literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding, if required.
• May assist with narrative writing.
• May assist with coding events, medical history, concomitant medications, and tests.
• May assist in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Validation of xEVMPD product records, including appropriate coding of indication terms using MedDRA, if required.
• Manual recoding of un-recoded product and substance terms arising from ICSRs if required.
• Identification and management of duplicate ICSRs if required.
• Activities related to SPOR / IDMP if required.
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
• Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process.
• Fosters constructive and professional working relationships with all project team members, internal and external.
• Participates in audits as required/appropriate.
• Applies safety reporting regulatory intelligence maintained by Syneos Health, or our customers, to all safety reporting activities, if required.
Candidate Profile
• M.Pharm, Pharm.D, M.Sc + B.Pharm. , BHMS, BDS or Ph.D. (Pharmacy) passed out in the year 2025.
• Candidates with the above healthcare educational backgrounds passed out in the year 2024, who have a strong interest in Pharmacovigilance may only apply.
• Strong knowledge and interest in a healthcare/scientific background is a must.
• Proficiency in Microsoft Office Suite and Outlook.
• Strong organizational, documentation, and multitasking skills.
• Excellent written and verbal communication.
• Ability to collaborate effectively in a team environment.
• High attention to detail and accuracy.
• Familiarity with safety databases, medical terminology, pharmacology, or pharmacovigilance.
• Experience with collaboration tools (Visio, Team Share, or equivalent).
Additional Information
Qualification : M.Pharm, Pharm.D, M.Sc + B.Pharm. , BHMS, BDS or Ph.D. (Pharmacy)
Location : Gurugram
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Safety & Pharmacovigilance
End Date : 20th September 2025
Safety & Pharmacovigilance - Trainee Apply
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