Pharmacovigilance Job at Syneos Health | B Pharm/ M Pharm & PharmD Graduates Eligible
This Syneos Health jobs listing is for the Safety & PV Specialist (SS I) – Night Shift position in Gurugram. B Pharm, M Pharm, BDS, BMS, and MBBS graduates are eligible to apply.
Syneos Health Job Details
Job Title: Safety & PV Specialist (SS I) – Night Shift
Location: Gurugram
Job Type: Full time
Job Requisition ID: 25110762
Posted On: Today
Job Responsibilities
- Applicants should be willing to work in night shift.
- The work location is Gurugram, candidate should be willing to work at Gurugram office.
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
- Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
- Triages ICSRs, 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 ICSRs.
- Identification and management of duplicate ICSRs.
- Activities related to SPOR / IDMP.
- Quality review of ICSRs.
- 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.
Syneos Health Jobs: Eligibility Criteria
Education: B. Pharm / M. Pharm / BDS / BMS / MBBS (No BSc / MSc)
Location: Gurugram Office based; this Syneos Health jobs opening requires work from the Gurugram office.
Skill for Sr Safety & PV Specialist: ICSR case processing experience along with Quality Check (QC) Experience is mandatory
Experience:
- Safety & PV Specialist l- Minimum 2.6 – 4 Years of PV experience
- Immediate/Early joiners will be preferred
Applicants should be fine to work from night shift.
Additional Information
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.