Are you a medical professional passionate about ensuring drug safety and advancing patient health? ProPharma, a global leader in life sciences consulting, is hiring a Drug Safety Physician in India to join its dynamic pharmacovigilance team. With over 20 years of expertise, ProPharma empowers biotech, medical device, and pharmaceutical organizations to deliver innovative therapies. This full-time role offers a unique opportunity to contribute to patient safety through medical review, signal detection, and risk management. Read on to discover how you can make an impact with ProPharma.
Responsibilities of a Drug Safety Physician
As a Drug Safety Physician at ProPharma, you will play a critical role in ensuring the safety of pre- and post-market drugs and devices. Key responsibilities include:
- Conducting medical review of safety events (pre-marketing, post-marketing, drug, and device) per project-specific procedures.
- Supporting signal detection and risk management activities by reviewing relevant safety information.
- Performing safety reviews of clinical and diagnostic data for case processing and aggregate reporting.
- Reviewing and contributing to aggregate reports such as PSUR, PBRER, DSUR, and ASR.
- Conducting literature reviews and refining literature search strategies for pharmacovigilance.
- Serving as the primary pharmacovigilance point of contact for clients throughout project lifecycles.
- Participating in signal management committees and client meetings, including Investigator meetings.
- Providing input for Company Core Data Sheet/Core Safety Information and Product Information.
- Guiding staff on regulatory reporting of adverse events and assisting with project-specific procedure development.
- Collaborating with peer and vendor medical reviewers to assess expert outcomes for safety reports.
- Supporting the Qualified Person for Pharmacovigilance (QPPV) and management as needed.
- Providing training on medically relevant topics and performing other duties as assigned.
Qualifications and Skills
To excel in this role, candidates should meet the following requirements:
- Medical degree (MBBS, MD, or equivalent) with a valid medical license.
- Experience in pharmacovigilance or drug safety, preferably in pre- and post-marketing environments.
- Strong understanding of regulatory reporting requirements for adverse events.
- Expertise in signal detection, risk management, and medical review of clinical data.
- Familiarity with aggregate reporting (PSUR, PBRER, DSUR, ASR).
- Excellent analytical, communication, and collaboration skills.
- Ability to work in a fast-paced, client-facing environment and manage multiple projects.
- Knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, GVP).
- Prior experience in literature reviews and safety database systems is a plus.
Why Join ProPharma?
ProPharma fosters a diverse, equitable, and inclusive workplace where employees can thrive as their authentic selves. Benefits include:
- Impactful Work: Contribute to patient safety and innovative therapies in a globally recognized organization.
- Career Growth: Access opportunities for professional development in pharmacovigilance and regulatory sciences.
- Collaborative Culture: Work with a team of experts in a supportive, entrepreneurial environment.
- Flexible Consulting Model: Engage in an advise-build-operate approach to de-risk high-profile programs.
- DEI Commitment: Be part of a company that celebrates diversity and empowers innovation.
How to Apply
