Syneos Health - Pharmacovigilance Safety & Pv Specialist I Openings

Syneos Health Hiring Safety & Pharmacovigilance Specialist I – B.Pharm / M.Pharm / PharmD | Gurugram & Hyderabad

Syneos Health is currently recruiting for the position of Safety & Pharmacovigilance (PV) Specialist I within its global drug safety and pharmacovigilance operations team. This full‑time onsite opportunity is available in Gurugram and Hyderabad, India and is designed for professionals with at least 2 years of pharmacovigilance or drug safety experience.

The vacancy falls under the Pharmacovigilance and Drug Safety department, where professionals contribute to adverse event case processing, safety database management, and regulatory safety reporting for clinical trials and post‑marketing surveillance programs.

Candidates with qualifications such as B.Pharm, M.Pharm, PharmD, or BDS and experience in ICSR case processing, drug safety databases, MedDRA coding, and clinical trial safety monitoring are ideal for this role. Professionals working in CROs, pharmaceutical companies, or drug safety outsourcing organizations will find this opportunity aligned with long‑term career growth in pharmacovigilance and regulatory drug safety.

This role allows professionals to work with global clinical development teams while contributing to safety monitoring activities that support the development and commercialization of new medicines worldwide.

Company Overview

Syneos Health is a leading global biopharmaceutical solutions organization that integrates clinical development, medical affairs, and commercialization services. The company collaborates with pharmaceutical, biotechnology, and healthcare organizations to accelerate the development and delivery of innovative therapies to patients worldwide.

With more than 29,000 employees across 110 countries, Syneos Health provides comprehensive support throughout the drug development lifecycle—from early clinical trials to post‑marketing safety surveillance.

Over the past five years, Syneos Health has contributed to the development of 94% of newly approved FDA drugs and 95% of EMA‑authorized medicines, demonstrating its strong influence in global clinical research and pharmacovigilance operations.

The organization focuses on patient‑centric clinical development models and uses advanced analytics, medical expertise, and operational excellence to ensure safe and effective therapies reach patients faster.

Job Role & Responsibilities

The Safety & PV Specialist I is responsible for supporting pharmacovigilance activities related to adverse event reporting, safety database management, and regulatory compliance across clinical trials and post‑marketing programs.

• 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 testsCompiles 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.

Eligibility / Qualifications

Educational Qualification

Candidates must hold a degree in pharmacy, healthcare, or life sciences.

Relevant Courses: B.Pharm, M.Pharm, PharmD, BDS, BSc Life Sciences, MSc Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research, Pharmacology.

Experience

• Minimum 2 years of pharmacovigilance or drug safety experience.
• Experience in clinical trial safety case processing or literature case processing is preferred.

Required Skills

• Knowledge of ICSR processing and pharmacovigilance workflows.
• Familiarity with safety databases and drug safety reporting systems.
• Understanding of ICH‑GCP, GVP guidelines, and drug development processes.
• Experience with MedDRA coding and medical terminology.
• Strong attention to detail and analytical skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Strong written and verbal communication abilities.

Professionals who can manage safety case timelines, maintain accuracy, and ensure regulatory compliance will succeed in this position.

Location & Salary

Job Locations: Gurugram, Haryana and Hyderabad, Telangana – India
Employment Type: Full‑Time Onsite

Salary information has not been publicly disclosed. Compensation will align with industry standards for pharmacovigilance professionals working in global CRO organizations.

Application Process

Interested candidates can apply directly through the official Syneos Health careers portal using the link below:

Apply Here:
https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Gurugram/Safety—PV-Specialist-I—Literature-review_25111537

Ensure that your resume highlights experience in pharmacovigilance case processing, safety databases, regulatory drug safety, and MedDRA coding.

Frequently Asked Questions (FAQs)

1. Who can apply for the Safety & PV Specialist role at Syneos Health?

Candidates with degrees such as B.Pharm, M.Pharm, PharmD, or BDS and at least two years of pharmacovigilance experience can apply.

2. Is pharmacovigilance experience mandatory?

Yes. Applicants must have a minimum of two years of relevant drug safety or pharmacovigilance experience.

3. What type of organization is Syneos Health?

Syneos Health is a global contract research and biopharmaceutical services company supporting drug development, clinical trials, and pharmacovigilance operations.

4. What career opportunities exist after this role?

Professionals can advance to Senior PV Specialist, Drug Safety Associate, Safety Scientist, or Pharmacovigilance Manager roles.

5. What regulatory guidelines are important for this job?

Knowledge of ICH‑GCP, GVP guidelines, and global pharmacovigilance regulations is important for performing safety reporting tasks.

Recruitment Summary

Tagged as: Case Processing, Clinical Research, Clinical Trials, Drug Safety, ICSR, MedDRA, Pharmacovigilance, Qualification, Regulatory Compliance, Validation