Senior Drug Safety Physician (Aggregate Reporting)

TL;DR

Senior Drug Safety Physician (Pharmacovigilance): Performing medical review and oversight of safety deliverables, including ICSRs, signal management, and periodic aggregate reports, with an accent on medical review for seriousness, expectedness, and causality. Focus on ensuring the medical and clinical integrity of data and managing risk/benefits evaluations for investigational and marketed products.

Company

Technology-led healthcare solutions provider enabling healthcare organizations to be future-ready.

What you will do

• Perform medical review of adverse events, assessing seriousness, expectedness, and causality for investigational and marketed products.
• Oversee ICSRs and literature surveillance for expedited and periodic submissions as per regulations and SOPs.
• Identify and validate potential signals based on a review of all sources and provide data for aggregate reports.
• Responsible for the medical review and oversight of PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, and RMPs.
• Contribute to pharmacovigilance and risk management planning by preparing safety surveillance strategies.
• Interface with clients on a regular basis to meet expectations and ensure clinical integrity of data.

Requirements

• Medical degree (M.B.B.S/MD/MS/DNB).
• Minimum 3 years of relevant experience within Pharmacovigilance, hospital, or pharmacy.
• At least 1 year of experience in the medical review of aggregate reports.
• Knowledge of global regulatory documentation, drug development processes, and guidelines.
• Proficiency in document management systems and applications such as Excel and Outlook.
• Strong written and verbal communication skills.

Nice to have

• Strong interpersonal skills and ability to be flexible in varying environments.
• Good mentoring skills.

Culture & Benefits

• Accelerated global growth opportunities for bold and industrious talent.
• Entrepreneurial environment with a focus on creating leaders of tomorrow through mentorship.
• Culture of inclusion and diversity as an Equal Opportunity Employer.
• Work at the convergence of healthcare and technology in a purpose-driven team.