Syneos Health has announced a Safety & PV Specialist – Future Roles (India) opportunity for candidates interested in building a career in Pharmacovigilance (PV), Drug Safety and Clinical Safety. The positions are expected to be based in Hyderabad and Gurugram under a hybrid work model.

This opportunity is particularly relevant for candidates with backgrounds in life sciences, pharmacy or nursing who have knowledge of safety databases, medical terminology, ICSR processing and pharmacovigilance regulations.

Candidates should note that this is a future opportunity/talent pipeline posting rather than confirmation of an immediately available vacancy. Applicants expressing interest may be considered when suitable Safety & PV Specialist positions become available at Syneos Health.

Syneos Health Safety & PV Specialist – Job Overview

About Syneos Health

Syneos Health is a fully integrated biopharmaceutical solutions organization providing clinical, medical affairs and commercial services to pharmaceutical and biotechnology companies.

According to the employer’s job description, Syneos Health operates globally with approximately 29,000 employees across 110 countries and supports drug development across clinical research and commercialization.

The Safety & PV Specialist job in India is focused on pharmacovigilance operations, including individual case safety report processing, safety database activities, MedDRA coding, literature review, regulatory reporting and safety documentation.

Key Responsibilities

Candidates selected for a Safety & PV Specialist role at Syneos Health may be responsible for:

• Entering information into pharmacovigilance quality and tracking systems for the receipt and tracking of Individual Case Safety Reports (ICSRs).
• Assisting with ICSR processing according to Standard Operating Procedures (SOPs) and project-specific safety plans.
• Triaging ICSRs and reviewing safety information for completeness, accuracy and regulatory reportability.
• Entering adverse event and safety information into safety databases.
• Coding adverse events, medical history, concomitant medications and relevant tests.
• Preparing complete and accurate patient narrative summaries.
• Identifying missing information and raising follow-up queries until discrepancies are appropriately resolved.
• Supporting timely submission of expedited safety reports according to applicable regulatory requirements.
• Maintaining safety tracking records for assigned pharmacovigilance activities.
• Performing literature screening and safety literature review.
• Supporting drug coding and maintenance of drug dictionaries.
• Performing MedDRA coding where required.
• Validating and submitting xEVMPD product records, including appropriate coding of indication terms.
• Performing manual recoding of un-coded product and substance terms arising from ICSRs.
• Identifying and managing potential duplicate ICSRs.
• Supporting activities associated with SPOR and IDMP.
• Performing quality review of ICSRs.
• Ensuring relevant safety documentation is submitted to the Trial Master File (TMF) for clinical trials.
• Supporting Pharmacovigilance System Master File documentation for post-marketing programs where applicable.
• Maintaining compliance with SOPs, Work Instructions, GCP, ICH guidelines, GVP and applicable global safety regulations.
• Working collaboratively with internal and external project stakeholders.
• Participating in audits when required.
• Applying applicable safety reporting regulatory intelligence to pharmacovigilance activities.

Qualification & Eligibility

Candidates interested in the Syneos Health Safety & PV Specialist jobs in India should meet the following educational requirements:

Educational Qualification:

• Bachelor’s Degree in Life Science, OR
• Registered Nurse, OR
• Pharmacist, OR
• An equivalent combination of education and relevant experience that provides the required knowledge and skills.

Candidates with B.Pharm, M.Pharm, Pharm.D, nursing and relevant life science backgrounds may therefore find the role aligned with their academic profile, subject to Syneos Health’s assessment of equivalency and the requirements of any future opening.

Skills Required

Applicants should preferably have knowledge or skills in:

• Pharmacovigilance and Drug Safety
• ICSR Processing
• Safety Database Systems
• Medical Terminology
• Adverse Event Processing
• MedDRA Coding
• Drug Coding
• Safety Narrative Writing
• Literature Screening
• Expedited Safety Reporting
• Duplicate Case Management
• xEVMPD
• SPOR / IDMP
• ICSR Quality Review
• TMF Documentation
• Clinical Trial Safety
• Post-Marketing Pharmacovigilance
• ICH-GCP
• Good Pharmacovigilance Practices (GVP)
• Microsoft Word, Excel and PowerPoint
• Microsoft Outlook
• Visio
• Shared content/workspace systems

Regulatory Knowledge

Candidates should have a good understanding of the clinical trial process across Phases II-IV and/or post-marketing safety requirements.

Knowledge of the following areas will be valuable:

ICH-GCP: Good Clinical Practice principles applicable to clinical research.

GVP: Good Pharmacovigilance Practices governing safety monitoring activities.

Safety Reporting Regulations: Requirements surrounding adverse event assessment, expedited reporting and regulatory submissions.

Clinical Trial Safety: Safety management and reporting requirements during clinical development.

Important Note About This Vacancy

Applicants should carefully understand the nature of this Syneos Health posting.

The company states that the advertisement is intended for a possible upcoming opportunity rather than a currently live role.

By expressing interest, candidates may be added to the company’s talent pipeline and considered if a suitable Safety & PV Specialist position becomes available.

Therefore, submitting an application or expression of interest does not guarantee an interview, vacancy or employment offer.

Why Consider Syneos Health?

Syneos Health highlights several employee development initiatives, including:

• Career development and progression opportunities
• Technical and therapeutic-area training
• Supportive line management
• Peer recognition programs
• Total rewards programs
• Exposure to global clinical research and pharmacovigilance operations
• Opportunities to collaborate with multidisciplinary teams
• Experience working within an international biopharmaceutical services organization

For pharmacovigilance professionals, the role can provide exposure to multiple areas of drug safety, including ICSR case processing, MedDRA coding, literature surveillance, safety databases, regulatory reporting and PV quality review.

Who Should Consider Applying?

This opportunity may be relevant for candidates seeking roles such as:

• Safety & PV Specialist
• Pharmacovigilance Specialist
• Drug Safety Associate
• Patient Safety Associate
• ICSR Case Processor
• Clinical Safety Associate
• Pharmacovigilance Associate
• Safety Data Specialist

Applicants should review their experience against the job requirements, particularly knowledge of safety database systems and medical terminology, which Syneos Health specifically identifies as required.

How to Apply

Application Link