Drug Safety Physician

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

• Provides medical review of safety events (pre-marketing, post-marketing, device, and drug) and/or other medically related information per assigned tasks and project-specific procedures.
• Provides input and review relevant safety information for signal detection and risk management activities.
• Performs safety review of clinical and diagnostic data as part of case processing and aggregate reporting.
• Provide medical review of aggregate reports (e.g., PSUR, PBRER, DSUR, and ASR).
• Literature and medical review of the literature search strategy.
• Serves as the main pharmacovigilance/safety physician point of contact for the customer for the life cycle of assigned projects.
• Is a member of the signal management committee.
• Assists with identifying out of scope activities in conjunction with the PV Project lead (as applicable).
• Attends project team and client meetings (including Investigator meetings) and teleconferences as required.
• Participates in Business Development activities as requested.
• Performs other activities as identified and requested by management.
• Provides input and consultancy to the client in the course of generation of the Company Core Data Sheet/Core Safety Information and Product Information.
• Provides guidance to Pharmacovigilance and Safety Services staff with regards to the regulatory reporting of adverse events.
• Assists with generation of project specific procedures (medical review workflow activities).
• Supports QPPV and management as required.
• Must regularly liaise with peer medical reviewers and also with vendor medical reviewers in assessing expert outcomes or opinions for all Safety reports.
• Provides training on medically relevant topics, as and when required.
• Providing oversight for overall PV and medical science for relevant medical products.
• Other duties as assigned.
  
  

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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