Safety & PV Specialist (SS I) - Night Shift (Gurugram)

Syneos Health, Inc.; India; On-site; INR 750,000 - 1,200,000; Full time

Job summary

Syneos Health, Inc. is seeking a Safety & PV Specialist (SS I) for the night shift at the Gurugram office. Responsibilities include entering IC/ICSR data, safety coding, and generating narratives within global regulatory timelines.

The role requires a B. Pharm / M. Pharm / BDS / BMS / MBBS degree and 2.6–4 years of PV experience, with ICSI case processing and QC experience being mandatory. Night shift availability is required.

Qualifications

• Experience with ICSI case processing and quality checks.
• Strong understanding of PV safety data entry and coding would be a plus.
• Ability to work night shifts and in Gurugram location.

Responsibilities

• Enter information into PV systems for receipt and tracking of ICSR.
• Assist in processing IC and other safety data tasks.
• Triages and codes safety events and medical history.
• Prepare complete narrative summaries for safety reports.
• Ensure timely and accurate reporting in compliance with regulatory guidelines.
• Maintain safety tracking for assigned activities.
• Support SPOR/IDMP activities and TMF submissions.

Skills

ICSI case processing

Quality Check

Education

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

Job description

Safety & PV Specialist (SS I) - Night Shift (Gurugram)

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.

WORK HERE MATTERS EVERYWHERE

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

• - Applicants should be willing to work in night shift.
• - The work location is Gurugram, candidate should be willing towork at Gurugram office.
• - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• - Assists in the processing of IC
• - Assists in the processing of IC
• - Triages
• - 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
• - Identification and management of duplicate IC
• - Activities related to SPOR / IDMP.
• - Quality review of IC
• - 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 Office based
• Skill for Sr Safety & PV Specialist: ICSI 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

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

http://www.syneoshealth.com

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. Occasio