Safety & PV Specialist II (MIS)
Location: Gurugram, India
Updated: October 30, 2025
Job ID: 25999948
Company: Syneos Health®
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We combine deep clinical, medical affairs, and commercial insights to deliver innovative solutions addressing today’s market realities.
Our Clinical Development model places patients and customers at the heart of everything we do. We continuously improve our systems to make Syneos Health both easier to work with and to work for, creating an environment that encourages innovation, teamwork, and purpose-driven performance.
With 29,000 employees across 110 countries, Syneos Health has contributed to:
94% of all Novel FDA Approved Drugs
95% of EMA Authorized Products
200+ studies across 73,000 sites and 675,000+ trial patients
Work Here Matters Everywhere.
Why Join Syneos Health
At Syneos Health, we are passionate about:
Career Development & Growth – structured training and advancement opportunities
Engaged Leadership – supportive management focused on your professional success
Recognition & Rewards – peer acknowledgment and total rewards program
Inclusive Culture – a Total Self culture where authenticity and diversity are celebrated
We believe that bringing together different perspectives, cultures, and backgrounds creates an environment where everyone feels valued and empowered to contribute their best.
Job Summary
The Safety & PV Specialist II (MIS) plays a vital role in supporting pharmacovigilance (PV) operations through data management, reporting, and coordination activities. This position involves working with safety data, maintaining compliance with regulatory requirements, and ensuring the accuracy and timeliness of reports and metrics for internal and client use.
Key Responsibilities
Support safety and PV data management activities, including case handling, tracking, and follow-up.
Manage and analyze safety databases to generate MIS reports, KPIs, and dashboards for PV teams and leadership.
Perform quality checks and data validation to ensure accuracy of safety information and compliance with SOPs and regulations.
Collaborate cross-functionally with global PV teams to streamline workflows and improve operational efficiency.
Assist in regulatory and audit readiness by maintaining documentation and metrics for inspections.
Contribute to process improvement initiatives and automation of PV data reporting.
Ensure compliance with ICH, GVP, and local regulatory requirements.
Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related discipline.
2–4 years of experience in Pharmacovigilance (MIS/reporting experience preferred).
Strong knowledge of safety databases (e.g., ARISg, Argus, or similar).
Proficiency in MS Excel, Power BI, or other data visualization tools for MIS generation.
Familiarity with PV regulations and case processing workflows.
Excellent communication, analytical, and organizational skills.
Additional Information
Responsibilities may evolve as per business requirements.
Equivalent education, experience, or training may be considered.
Syneos Health is committed to equal opportunity employment and compliance with the EU Equality Directive and the Americans with Disabilities Act (ADA).
Reasonable accommodations will be provided to enable employees or applicants to perform essential job functions.
How to Apply
Interested candidates can apply via the Syneos Health Careers Portal or join our Talent Network to stay updated on future opportunities.
At Syneos Health, we value transferable skills and encourage applications even if your experience doesn’t perfectly match every qualification listed.
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