Safety Specialist III
Location: Remote, India
Job ID: R-01243764
Job Type: Full-time
Category: Clinical Research
Remote: Fully Remote
About Us:
Our team in clinical research services is dedicated to bringing cures to market. We provide top-tier scientific and clinical expertise to develop drugs that address the world’s most challenging health concerns. As part of our PPD® clinical research portfolio within our global contract research organization (CRO), we are at the forefront of clinical research and drug development.
Job Description:
The Safety Specialist III is responsible for performing and overseeing day-to-day pharmacovigilance (PV) activities in a highly regulated environment with strict timelines. The role includes collection, monitoring, assessment, evaluation, research, and tracking of safety information. The Safety Specialist III collaborates with various stakeholders such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors. This role operates independently and may participate in on-call duties for specific projects to ensure 24-hour coverage for intake of cases from investigative sites.
Key Responsibilities:
- Pharmacovigilance Activities: Perform day-to-day PV activities including collection, monitoring, assessment, evaluation, research, and tracking of safety information.
- Collaboration: Effectively collaborate with project team members, client contacts, investigators, adverse event reporters, and third-party vendors.
- Leadership: Operate in a lead capacity, providing assistance in the development of program and departmental procedural documents. Mentor less experienced staff.
- Audits: Prepare for and attend audits as required.
- Regulatory Updates: Stay updated on current regulations, practices, procedures, and proposals by reviewing regulatory/pharmacovigilance publications and information sources.
- Medical Understanding: Maintain a medical understanding of applicable therapeutic areas and disease states.
- Quality Review: Review cases for quality, consistency, and accuracy, including peer report review.
- Project Coordination: Handle routine project implementation and coordination, including presentations at client/investigator meetings and review of metrics and budget considerations.
- Literature Surveillance: Conduct assessment and peer review of literature abstracts/articles for adverse events, special situation events, signal-relevant and aggregate safety report-relevant safety information, and analysis of similar events for both developmental and market-authorized products.
- Primary Contact: Serve as the primary point of contact for low, medium, and high complexity literature projects.
- Compliance: Ensure literature surveillance tasks are conducted according to company policies, procedures, contractual agreements, and applicable regulations.
- Departmental Initiatives: Participate in departmental initiatives.
- Audits and Inspections: Prepare for and attend audits, inspections, and bid defenses as needed.
Qualifications:
- Education: Relevant Bachelor’s or advanced degree in life sciences, pharmacy, nursing, or a related field.
- Regulatory Knowledge: Thorough understanding of global pharmacovigilance regulations and guidelines.
- Skills:
- Strong analytical and problem-solving skills.
- Excellent written and oral communication skills.
- Proficient in using PV databases and other relevant IT applications.
- Ability to work effectively in a remote, team-oriented environment.
- Strong organizational and coordination abilities.
- Knowledge of therapeutic areas and disease states relevant to current projects.