Safety & PV Submission Specialist II (Gurugram/Hyderabad)
Hybrid · Hyderabad, Telangana, India or Gurugram, Haryana, India
Job Summary
Safety & PV Submission Specialist II responsibilities: Collaborate with the Sponsor and internal project management associates on the design, preparation and assembly of the expedited and periodic safety report documents; participate in project launch activities for safety reporting tasks; prepare Safety Reporting Plan for safety submissions only projects; maintain tracking of safety submissions; provide Sponsor/Customer with expedited and periodic safety report submission status updates as required; provide support and advice on expedited and periodic safety report issues to project team/Sponsor; apply safety reporting regulatory intelligence; file documents according to project-specific requirements; forward completed safety submission documents to clients and other relevant parties; act as a point of contact for regulatory issues related to safety submissions; may be responsible for distributing and monitoring team workload; fosters constructive and professional working relationships with project team members; assist in internal project review meetings; assist in tracking and measuring program/project progress via KPIs; participate in audits; ensure TMF and regulatory filing per SOPs and GCP standards; maintain understanding of SOPs/WIs, global drug/biologic/device regulations, ICH GCP and related PV processes; proficient in MS Office and related tools; travel minimal (up to 5%). This role requires a Bachelor’s degree in life sciences or equivalent and ~4 years of Safety and Pharmacovigilance experience, with capability to handle Safety Submissions and regulatory interactions in an Indian (IND) context; hybrid work arrangement in Gurugram/Hyderabad, India.
Required Qualifications
- Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
- Experience in a clinical research organization preferred with a minimum of 4 years' Safety and Pharmacovigilance experience required including safety submissions
- Experience in Safety Submissions to regulatory authorities (Ideal) sites and Ethics committee
- In-depth understanding of PV guidelines, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
- Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.
- Ability to work independently and in a team environment
- Strong communication, presentation, interpersonal skills, both written and spoken
- Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects
- Detail oriented with a high degree of accuracy and ability to meet deadlines
- Minimal travel may be required (up to 5%)
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