Compliance Officer - PV

RESPONSIBILITIES

• Ensure ongoing compliance with standard operating procedures.
• Act as liaison with auditors and regulatory inspectors and assume responsibility for ensuring corrective and preventive actions.
• Ensure ongoing compliance with local, national, and international pharmacovigilance standards and legislation.
• Create and maintain control documentation, including controlled copy of SOPs, training records etc.
• Identify relevant training needs and opportunities.
• Monthly random sampling of ICSRs and Periodic reports (around 5%) for compliance with respect to pharmacovigilance legislation.
• To conduct vendor audits and external audits as applicable
• To monitor CCPs and Deviations
• Any other responsibilities assigned by Head/ Designee.

DESIRED SKILLS

• Expert knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, GVP Modules; respective EU Clinical Trial Directive etc.)
• Good knowledge of regulatory documentation, drug development process and global regulations and guidelines.
• Ability to manage multiple and varied tasks and prioritize workload
• Attention to detail and decision-making skills.
• Knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
• Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting