Safety & PV Ops Specialist I
August 22, 2025
IND-Gurugram
25000428
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. Our Clinical Development model centers on the customer and patient, simplifying and streamlining processes to enhance collaboration and delivery of therapies. With over 29,000 employees across 110 countries, we foster an agile and inclusive environment passionate about changing lives.
Commitment to career development and progression
Supportive, engaged management and peer recognition programs
Total Self culture promoting authenticity and inclusivity
Emphasis on diversity, belonging, and employee well-being
Provide operational support across multiple areas within the Safety & Pharmacovigilance (PV) Business Unit. Support Safety Project delivery leads with training management, document filing, systems setup, and access requests. Assist with department-level tasks, process improvements, and tool development.
Develop and maintain repositories of relevant documents (training, finance, proposals, RFI library, metrics, audit/inspection lists).
Create and update job aids and process documentation.
Maintain knowledge of FDA/EU/ICH safety and PV reporting guidelines and regulations.
Facilitate SPVG Annual Revenue targets by collaborating with operational teams and Therapeutic BU Project Directors for accurate BU recognition in RBB.
Provide SPVG metrics as assigned.
Perform other duties as assigned.
Travel up to 15% may be required.
Support Quality Planning by managing controlled documents and quality metrics.
Facilitate Quality Compliance and quality control activities.
Assist Quality Assurance by identifying risks via risk-based assessments.
Provide expertise on procedures and Quality Issues (QIs), liaising with Corporate Quality Assurance.
Help maintain audit and inspection readiness for safety projects.
Plan, develop, track, and deliver training materials for Safety & Pharmacovigilance BU.
Liaise with leadership to update training content (e.g., Safety Specialist training, revenue recognition).
Oversee Learning Management System (LMS) for the BU.
Develop PV-specific training for accreditation programs.
Participate in audits and system demos.
Assist with implementation, validation, testing, and documentation of Safety Systems projects.
Develop and maintain departmental SOPs and Work Instructions related to Safety Systems.
Understand IT SOPs affecting Safety Systems business processes.
Analyze and support regulatory and customer reporting needs from Safety Systems.
Implement process efficiencies related to Safety & PV.
Configure, administer, and maintain Argus Safety database per project.
Support development and maintenance of Safety reporting tools (e.g., Business Objects).
Manage Argus project info, licenses, user access, and report requests.
Troubleshoot Argus and other Safety systems issues.
Assist with training development for Safety Systems and mentor junior specialists.
Support alternate sponsor database users (e.g., ArisG, Clintrace).
Maintain compliance with SOPs, global regulations, GCP, ICH guidelines, and drug development processes.
Participate in Safety System data migrations, custom reports, and quality checks.
Represent Safety Applications team in project and client meetings.
Maintain expertise through internal meetings and professional development.
Facilitate SPVG Annual Gross Profit targets by collaborating with operational teams.
Participate in Plan Activation Strategy calls and develop proposal strategies.
Ensure accuracy of SPVG budget, scope, and proposal text by working with relevant teams.
Liaise with Contracts, BU Project Managers, and Safety Project Managers on scope/budget changes.
Maintain template proposal texts and slides; regularly update SPVG costing model elements.
Attend bid defense and project hand-over meetings as needed.
Bachelor’s degree in life sciences, nursing, pharmacy, computer science, technology, or equivalent experience.
Experience with Safety Database systems and medical terminology.
Preferred: Clinical research, data collection/computer systems, or pharmaceutical/CRO industry experience (technical role).
Strong computer skills, familiarity with relational databases (Oracle Insight/Analytics/Data Mart, Crystal Reports/Business Objects, SQL Plus preferred).
Excellent knowledge of ICH guidelines and safety/pharmacovigilance regulations.
Proficient in Microsoft Office Suite (Word, Excel, Visio, PowerPoint), Outlook, and internet.
Ability to work independently and collaboratively.
Strong organizational, documentation, and multitasking abilities.
Detail-oriented with high accuracy and deadline management skills.
Effective decision-making skills.
Excellent communication and interpersonal skills, both written and verbal.
Minimal travel required (up to 15%).
Job duties may be adjusted as needed without prior notice.
Equivalent experience or education may be considered.
Commitment to equal employment opportunity and compliance with applicable laws including ADA accommodations.
Syneos Health has supported 94% of novel FDA-approved drugs, 95% of EMA-authorized products, and managed over 200 studies across 73,000 sites and 675,000+ trial patients in the past five years.
Apply online or join the Talent Network to stay connected with future opportunities.
Syneos Health fosters a diverse, inclusive, and authentic workplace where transferable skills are valued. Candidates with non-traditional backgrounds are encouraged to apply.
Learn more about Syneos Health: www.syneoshealth.com
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