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Syneos Health
Looking to advance your career in Pharmacovigilance and Drug Safety? Syneos Health is hiring Safety & PV Submission Specialist II for its offices in Gurugram and Hyderabad, India. This is an excellent opportunity for experienced Pharmacovigilance professionals with expertise in safety submissions, regulatory compliance, and clinical trial safety reporting.
Job Details
Position: Safety & PV Submission Specialist II
Location: Gurugram / Hyderabad, India
Company: Syneos Health
Department: Safety & Pharmacovigilance
Experience Required: Minimum 4 Years
Employment Type: Full-Time
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization that helps customers accelerate the development and commercialization of innovative therapies. With more than 25,000 professionals worldwide, the company supports pharmaceutical, biotechnology, and healthcare organizations across the entire drug development lifecycle.
Key Responsibilities
As a Safety & PV Submission Specialist II, you will:
- Collaborate with sponsors and project teams to prepare expedited and periodic safety reports.
- Participate in project launch activities related to safety reporting.
- Prepare Safety Reporting Plans for safety submission projects.
- Maintain and monitor safety submission tracking systems.
- Provide submission status updates to sponsors and customers.
- Support project teams with safety reporting and regulatory compliance issues.
- Apply global safety reporting regulations and intelligence to submissions.
- Manage documentation filing according to project requirements.
- Distribute completed safety submission documents to clients and stakeholders.
- Act as a regulatory contact for safety submission-related issues.
- Assist in workload management and team coordination.
- Participate in project review meetings and audits.
- Ensure proper filing of documents within Trial Master Files (TMF) and Pharmacovigilance System Master Files.
- Maintain compliance with SOPs, ICH-GCP, GVP, FDA, EMA, and India regulatory requirements.
Eligibility Criteria
Candidates should possess:
- Bachelor’s Degree in Life Sciences, Pharmacy, Nursing, or an equivalent qualification.
- Minimum 4 years of Safety and Pharmacovigilance experience.
- Experience in safety submissions to regulatory authorities, ethics committees, and clinical sites.
- Experience leading safety submission projects.
- Strong knowledge of TMF filing and oversight.
- Thorough understanding of Pharmacovigilance guidelines, including FDA, EMA, and Indian regulations.
- Experience with safety databases and medical terminology.
- Knowledge of clinical trial processes (Phase II-IV) and post-marketing safety requirements.
- Proficiency in Microsoft Office Suite, Outlook, Visio, and collaboration platforms.
- Excellent communication, presentation, and interpersonal skills.
- Strong organizational and multitasking abilities.
- High attention to detail and ability to meet deadlines.
Preferred Skills
- Clinical Research Organization (CRO) experience.
- Strong understanding of ICH-GCP and Global Pharmacovigilance Practices.
- Ability to work independently and collaboratively in cross-functional teams.
- Effective decision-making and problem-solving capabilities.
Why Join Syneos Health?
Syneos Health offers:
- Career development and growth opportunities.
- Comprehensive technical and therapeutic training programs.
- Supportive leadership and collaborative work environment.
- Employee recognition and rewards programs.
- Inclusive and diverse workplace culture.
- Opportunities to work on global clinical research and pharmacovigilance projects.
How to Apply
Interested candidates can apply directly through the official Syneos Health Careers portal and explore this exciting opportunity to contribute to global drug safety and patient care.
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To apply for this job please visit syneoshealth.wd12.myworkdayjobs.com.
