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Safety & Pharmacovigilance Trainee (Contractual)

2+ years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Full Time Education: M.Pharm, Pharm.D, M.Sc + B.Pharm, BHMS, BDS, or Ph.D. (Pharmacy) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Safety & Pharmacovigilance Trainee (Contractual)


Company

Syneos Health®
Location: Gurugram, India
Job ID: 25101070
Updated: September 2, 2025


About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success by delivering innovative clinical, medical affairs, and commercial solutions. With over 29,000 employees in 110 countries, Syneos Health fosters a culture of diversity, inclusivity, and continuous development.


Position Summary

As a Safety & Pharmacovigilance Trainee, you will undergo training and mentorship to assist with key pharmacovigilance activities, including the preparation and processing of Individual Case Safety Reports (ICSRs), literature screening, drug coding, data management, and regulatory reporting. You will adhere to data privacy, Good Clinical Practices (GCP), regulatory guidelines, and project-specific procedures. Based on performance, trainees may transition into project roles post comprehensive training.


Key Responsibilities

  • Monitor and route incoming safety information to relevant projects.

  • Record and track ICSR documentation as per sponsor/customer specifications.

  • Redact patient-identifying information in line with data protection, ICH GCP, and GVP guidelines.

  • Assist in data entry and case creation in safety databases.

  • Perform file creation, tracking, retention, and maintenance (both electronic and paper).

  • Manage document translation processes as needed.

  • Support query follow-up and submission processes.

  • Assist in daily workflow reconciliation.

  • Participate in safety literature screening, drug coding, MedDRA coding, and maintenance of drug dictionaries.

  • Support narrative writing, coding of events, medical history, concomitant medications, and tests.

  • Aid in the preparation and submission of expedited safety reports in compliance with regulatory requirements.

  • Validate xEVMPD product records and perform manual recoding as needed.

  • Identify and manage duplicate ICSRs.

  • Conduct activities related to SPOR / IDMP.

  • Ensure submission of relevant documents to Trial Master File (TMF) and Pharmacovigilance System Master File.

  • Maintain knowledge of SOPs, Work Instructions, GCP, ICH guidelines, GVP modules, and drug development processes.

  • Foster professional relationships within project teams.

  • Participate in audits as required.

  • Apply regulatory intelligence in safety reporting activities.


Qualifications

Education & Eligibility

  • M.Pharm, Pharm.D, M.Sc + B.Pharm, BHMS, BDS, or Ph.D. (Pharmacy)

  • Passed out in 2025 (2024 passouts with strong interest in Pharmacovigilance may also apply)

Core Skills

  • Strong knowledge and interest in healthcare/scientific fields

  • Proficiency in Microsoft Office Suite and Outlook

  • Excellent organizational, documentation, multitasking skills

  • Strong written and verbal communication skills

  • Ability to work collaboratively in a team environment

  • High attention to detail and accuracy

Preferred Qualifications

  • Familiarity with safety databases, medical terminology, pharmacology, or pharmacovigilance

  • Experience with collaboration tools like Visio, Team Share, or equivalents


Employment Type

  • Contractual role for 1 year (extension subject to performance and business needs)


Additional Information

  • Tasks and responsibilities may vary based on company discretion.

  • The company complies with all applicable employment legislation and promotes diversity and inclusion.

  • Reasonable accommodations will be provided as required under the Americans with Disabilities Act.


Why Work With Syneos Health?

  • Strong career development and progression opportunities

  • Supportive and engaging management

  • Comprehensive training programs

  • Inclusive “Total Self” culture where employees can be authentic

  • Commitment to diversity and belonging


Application

Interested candidates can apply for the position or join the Syneos Health Talent Network for future opportunities.

Learn more: Syneos Health Website