Safety & PV Specialist II (Night Shift)

Syneos Health, Inc.; Hyderabad; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Syneos Health, Inc. is hiring for a Safety and Pharmacovigilance Specialist in Hyderabad, India. The ideal candidate should possess a B. Pharm / M. Pharm / BDS / BMS / MBBS and have relevant experience in safety reporting and data entry. Responsibilities include managing ICSR data, ensuring compliance with safety regulations, and working during night shifts. The company encourages immediate joiners and values attention to detail and communication skills.

Qualifications

• Minimum 2.6 years experience for Safety & PV Specialist I.
• Minimum 4 years experience for Safety & PV Specialist II.
• Immediate/Early joiners will be preferred.

Responsibilities

• Work from night shift as required.
• Enter information into PVG quality and tracking systems.
• Evaluate ICSR data for completeness and accuracy.
• Assist in generating accurate reporting of expedited reports.
• Conduct literature screening and review for safety.

Skills

Attention to detail

Data entry

Knowledge of safety regulations

Communication skills

Education

B. Pharm / M. Pharm / BDS / BMS / MBBS

Job description

Job Responsibilities

• Applicants should be fine to work from night shift
• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• Assists in the processing of IC SRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
• Triages IC SRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
• Enters data into safety database.
• Codes events, medical history, concomitant medications, and tests.
• Compiles complete narrative summaries.
• Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
• Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Maintains safety tracking for assigned activities.
• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
• Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
• Manual recoding of un-recoded product and substance terms arises from IC SRs.
• Identification and management of duplicate IC SRs.
• Activities related to SPOR / IDMP.
• Quality review of IC SRs.
• 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 and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/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 to all safety reporting activities.

Qualifications

• Education: B. Pharm / M. Pharm / BDS / BMS / MBBS (No BSc / MSc)
• Safety & PV Specialist I – Minimum 2.6 Years
• Safety & PV Specialist II – Minimum 4 Years
• Immediate/Early joiners will be preferred
• Applicants should be fine to work from night shift

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.