Safety & PV Specialist- Future Roles (India)

Syneos Health, Inc.; Gurugram District; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Syneos Health in India seeks a Safety & PV Specialist for future roles to support pharmacovigilance activities. You will manage ICSR processing, data entry in safety databases, and MedDRA coding while ensuring regulatory compliance with GCP and GVP standards.

The role requires a life sciences degree, strong communication, and the ability to work both independently and within a team. Quality-driven with attention to detail is essential.

Qualifications

• Bachelor’s degree in life science, nursing or pharmacy with relevant experience in pharmacovigilance or safety.
• Safety Database systems and knowledge of medical terminology required.
• Good understanding of clinical trial process and safety regulations (ICH GCP, GVP).
• Proficiency in Microsoft Office; strong written and spoken communication.
• Ability to work independently and in teams, with strong organizational skills.

Responsibilities

• Enter information into PVG quality and tracking systems for receipt and processing of ICSR per SOPs.
• Triages ICSR, checks data for completeness and regulatory reportability; enters data into safety databases.
• Compile complete narrative summaries and follow up on queries to resolution.
• Literature screening and MedDRA coding as required; maintain drug dictionary.
• Validate and submit xEVMPD records; ensure TMF documents are archived.
• Support SPOR/IDMP activities and quality reviews of ICSR.
• Ensure adherence to SOPs, WIs, and global regulations; participate in audits as needed.
• Apply safety reporting regulatory intelligence to all safety activities.

Skills

ICSR processing

Safety database familiarity

MedDRA coding

GVP/ICH compliance

Microsoft Office

Communication skills

Education

Bachelor’s degree in life sciences / nursing / pharmacy

Regulatory knowledge (GCP)

Tools

MedDRA

Safety database systems

Microsoft Excel/Office

Job description

Safety & PV Specialist- Future Roles (India)

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

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of IC​SRs according to Standard Operating Procedures (SOPs) and project/program‑specific safety plans as required. Triages IC​SRs, 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​SRs.


• Identification and management of duplicate IC​SRs.


• Activities related to SPOR / IDMP.


• Quality review of IC​SRs.


• 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

• Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.


• Safety Database systems and knowledge of medical terminology required.


• Good understanding of clinical trial process across Phases II-IV and/or post‑marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.


• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.


• Ability to work independently and in a team environment.


• Excellent communication and interpersonal skills, both written and spoken.


• Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.


• Detail oriented with a high degree of accuracy and ability to meet deadlines.

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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Learn more about Syneos Health.

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. 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.

Summary

Roles within Pharmacovigilance & Safety job family are responsible for providing expertise on pharmacovigilance services. This includes participating in all aspects of the medical safety team's involvement in assigned trials, such as performing medical review and clarification of trial‑related Adverse Events, providing aggregate reviews of safety information, and serving as an internal consultant to pharmacovigilance case processing teams. Provides and contributes trends and safety signal detection and risk management assessment and provides safety support to the clinical development teams. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs and policies, using knowledge and skills typically acquired through advanced education. Entry to developing individual contributor. Delivers work of limited scope, typically smaller, less complex projects. Requires theoretical knowledge of a professional area, typically obtained through education and/or prior experience.