Safety & Pv Ops Specialist I

0-2 years

Not Disclosed

Hyderabad

10 Sept. 10, 2025

Job Description

Job Type: Hybrid Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Safety & PV Ops Specialist I

Company Overview:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By translating clinical, medical affairs, and commercial insights into measurable outcomes, we address modern market realities.

Our Clinical Development model places the customer and patient at the center of everything we do. Whether in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with passionate problem-solvers to innovate and deliver therapies that change lives.

With 29,000 employees across 110 countries, Syneos Health thrives on agility, innovation, and a shared purpose:

“WORK HERE MATTERS EVERYWHERE”

Why Join Syneos Health:

Career growth through training, development programs, and progression opportunities.
Supportive and engaged line management, peer recognition, and total rewards programs.
Inclusive Total Self culture, empowering you to be authentic at work.
Commitment to diversity of thought, background, and perspective, fostering belonging.

Role Summary:

The Safety & PV Ops Specialist I provides operational support across multiple areas within the Safety & Pharmacovigilance (SPVG) Business Unit (BU). You will assist Safety Project delivery leads with training, document management, system setup, access requests, process improvements, and tools development.

This role requires minimal travel (up to 15%).

Key Responsibilities:

General Operations:

Maintain and update repositories of documents including training materials, project finance records, proposals, RFIs, departmental metrics, and audits/inspections.
Develop and manage job aids, process documents, and supporting documentation.
Stay current on FDA/EU/ICH guidelines and regulations related to Safety and Pharmacovigilance.
Support SPVG annual revenue targets by collaborating with operational teams and BU Project Directors.
Provide SPVG metrics and reporting as required.
Perform other duties as assigned.

Quality & Compliance:

Support Quality Planning, including document control, development, review, and metrics tracking.
Facilitate Quality Compliance verification and Quality Assurance activities, including risk assessments and QI resolution.
Support Safety Project teams in maintaining audit and inspection readiness.

Training:

Develop, plan, track, and present training materials for Safety & PV BU.
Oversee Learning Management System (LMS) for training administration.
Design PV-specific training for accreditation programs.

Technology & Systems Support:

Participate in audits, system demos, and validation of Safety Systems projects.
Maintain SOPs, Work Instructions, and IT compliance related to Safety Systems.
Configure, administer, and maintain the Argus Safety database per project requirements.
Generate reports and perform quality checks for internal, client, and regulatory purposes.
Assist in training and mentoring junior Safety Application Specialists.
Advise users on alternate sponsor databases (e.g., ArisG, Clintrace).
Participate in Safety System data migrations and custom report generation.

Proposals & Financial Support:

Support SPVG gross profit targets by monitoring budget, scope, and resource allocation.
Develop proposal strategy and content in coordination with SPVG leadership.
Maintain template proposals, slides, and cost models, ensuring accuracy of hours and tasks.
Attend bid defense and project handover meetings as needed.

Qualifications:

Bachelor’s degree in Life Science, Nursing, Pharmacy, Computer Science, or related field (or equivalent experience).
Experience with Safety Database systems and moderate medical terminology.
Knowledge of ICH guidelines and pharmacovigilance regulations.
Clinical research, data collection, or CRO experience preferred.
Proficiency in Microsoft Office Suite, relational databases, SQL, Crystal Reports, and Business Objects.
Excellent communication, presentation, organizational, and documentation skills.
Ability to prioritize multiple tasks, work independently and collaboratively, and make effective decisions.

Additional Information:

Tasks may evolve as required; the Company reserves the right to assign other duties.
Compliance with local legislation and ADA accommodations is ensured.
Equivalent experience and transferrable skills will be considered.

About Syneos Health Impact:

Supported 94% of all novel FDA-approved drugs and 95% of EMA authorized products in the past 5 years.
Managed over 200 studies across 73,000 sites and 675,000+ trial patients globally.

Learn more: Syneos Health Website

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Safety & Pv Ops Specialist I

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