Safety & PV Specialist (SS I / SS II / Sr SS) - Night Shift

Syneos Health, Inc.; Gurugram District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Syneos Health is seeking a Safety & PV Specialist for night shift, based in Gurugram/Hyderabad/Pune offices. Senior roles require 6+ years in PV with ICSR processing and QC experience.

You will support data entry, coding, narrative summaries, and regulatory reporting within a global pharmacovigilance program. Responsibilities include safety database entries, literature screening, SPOR/IDMP activities, TMF submissions, and collaboration with cross‑functional teams.

Qualifications

• Education: B. Pharm / M. Pharm / BDS / BMS / MBBS (No BSc / MSc).
• Location: Gurugram-Hyderabad/Pune office based.
• Sr Safety & PV Specialist requires ICSR processing and QC experience.

Responsibilities

• Enter information into PV safety systems for receipt and tracking ICSR.
• Assist in processing of ICSRs according to SOPs and project safety plans.
• Triages ICSRs, evaluates data for completeness and regulatory reportability.
• Enter data into safety databases and code events, history, meds, tests.
• Compile complete narrative summaries for ICSRs.
• Identify information gaps and follow up until queries are resolved.
• Support timely, accurate reporting of expedited reports per regulatory requirements.
• Maintain safety tracking for assigned activities and quality reviews.

Skills

ICSR processing

Quality check

Medical coding

Team collaboration

Education

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

Job description

Safety & PV Specialist (SS I / SS II / Sr SS) - Night Shift

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.

Discover what our 29,000 employees, across 110 countries already know.

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• Must have 6 + yrs of experience in ICSR case processing and Quality Check /

Quality Review.

• Applicants should be willing to work in night shift.

- The work location is Hyderabad / Gurugram, candidate should be willing to

work at Hyderabad / Gurugram office.

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• Assists in the processing of IC​S​R​s according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
• Triages IC​S​Rs, 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​S​Rs.
• Identification and management of duplicate IC​S​Rs.
• Activities related to SPOR / IDMP.
• Quality review of IC​S​Rs.
• 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)

Location: Gurugram-Hyderabad/Pune Office based

Skill for Sr Safety & PV Specialist** :** ICSR case processing experience along with Quality Check (QC) Experience is mandatory

Experience-
Sr Safety & PV Specialist- Minimum 6 years of PV experience

Safety & PV Specialist l- Minimum 2.6 Years of PV experience

Safety & PV Specialist ll- Minimum 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.