Safety & PV Ops Specialist I – Salem, India
Join Syneos Health® as a Safety & PV Ops Specialist I and play a vital role in advancing drug safety and pharmacovigilance operations within a leading global biopharmaceutical solutions organization. Based in Salem, India, this role provides operational support across documentation, compliance, safety systems, training, and proposal development while ensuring regulatory adherence and quality delivery for Safety & Pharmacovigilance projects.
Expected Salary: Industry standard range for Safety & PV Ops Specialist roles in India is INR 6–10 LPA, depending on skills and experience.
As part of the Safety & Pharmacovigilance Business Unit (BU), you’ll collaborate with project managers, safety specialists, and leadership teams to support Argus Safety systems, audits, and training while contributing to proposal development and business targets.
Key Responsibilities
Maintain and manage safety documentation, departmental metrics, and PV repositories.
Support compliance, quality checks, and inspection readiness activities.
Develop and deliver PV training programs and manage the Learning Management System (LMS).
Configure, validate, and troubleshoot Argus Safety and other safety databases.
Generate and QC safety database reports for client, internal, and regulatory submissions.
Assist in proposal strategy, budget support, and business planning.
Collaborate cross-functionally to ensure timely and compliant project delivery.
Required Skills & Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Computer Science, or related field.
Experience with Safety Databases (Argus, ArisG, Clintrace) and medical terminology.
Strong understanding of ICH-GCP, FDA, EMA safety regulations, and pharmacovigilance standards.
Proficiency in SQL, Oracle, Business Objects, and MS Office Suite.
Excellent organizational, documentation, and multitasking abilities.
Strong communication and presentation skills.
CRO/pharmaceutical industry experience preferred.
Perks & Benefits
Competitive pay with performance-based incentives.
Professional development and career progression opportunities.
Training in therapeutic areas and safety systems.
Flexible and inclusive Total Self culture promoting diversity and well-being.
Work in a global environment with exposure to industry-leading projects.
About Syneos Health
Syneos Health® operates across 110 countries with 29,000 employees, supporting 94% of FDA-approved novel drugs in the last five years. The company partners with top pharmaceutical and biotech organizations to accelerate clinical development and improve patient outcomes.
Work Mode: Hybrid (Salem, India)
If you are passionate about pharmacovigilance, safety operations, and making an impact in global healthcare, apply now and be part of a team where Work Here Matters Everywhere.
Gujarat :
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Paris | Lyon |South Africa :
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