Syneos Health – Pharmacovigilance Safety & Pv Specialist I Openings
- Syneos Health Hiring Safety & Pharmacovigilance Specialist I – B.Pharm / M.Pharm / PharmD | Gurugram & Hyderabad
- Company Overview
- Job Role & Responsibilities
- Pharmacovigilance Case Processing
- Safety Data Management
- Regulatory Compliance & Reporting
- Quality & Documentation Activities
- Cross‑Functional Collaboration
- Eligibility / Qualifications
- Educational Qualification
- Experience
- Required Skills
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- 1. Who can apply for the Safety & PV Specialist role at Syneos Health?
- 2. Is pharmacovigilance experience mandatory?
- 3. What type of organization is Syneos Health?
- 4. What career opportunities exist after this role?
- 5. What regulatory guidelines are important for this job?
- Recruitment Summary
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.
Pharmacovigilance Case Processing
- Perform Individual Case Safety Report (ICSR) processing in accordance with sponsor requirements and regulatory guidelines.
- Enter and validate safety information within pharmacovigilance safety databases.
- Perform MedDRA coding for adverse events, medical history, medications, and laboratory data.
- Evaluate case information for completeness, regulatory reportability, and accuracy.
Safety Data Management
- Maintain safety tracking systems and ensure accurate case processing timelines.
- Identify duplicate safety reports and manage reconciliation activities.
- Conduct literature screening for drug safety information.
- Perform medical coding and maintain drug dictionaries used for safety reporting.
Regulatory Compliance & Reporting
- Support the preparation and submission of expedited safety reports according to global regulatory requirements.
- Assist in the validation and submission of xEVMPD product records.
- Participate in activities related to SPOR and IDMP regulatory frameworks.
- Ensure compliance with ICH‑GCP, GVP guidelines, and global pharmacovigilance regulations.
Quality & Documentation Activities
- Conduct quality review of ICSRs to maintain high safety data standards.
- Ensure all pharmacovigilance documentation is properly maintained within the Trial Master File (TMF).
- Participate in audits and inspections when required.
Cross‑Functional Collaboration
- Work with safety physicians, pharmacovigilance teams, and clinical operations staff.
- Maintain professional communication with internal and external stakeholders.
- Contribute to team discussions regarding safety trends and risk management 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:
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
| Company | Syneos Health |
|---|---|
| Vacancies | Safety & PV Specialist I |
| Required Education | B.Pharm, M.Pharm, PharmD, BDS or Life Sciences |
| Experience | Minimum 2 Years Pharmacovigilance / Drug Safety Experience |
To apply for this job please visit syneoshealth.wd12.myworkdayjobs.com.
