Job Title: Safety Physician I (GPV)
- Participate in or lead safety management teams for clinical programs;
- Serve as the safety point of contact to other colleagues (Regulatory Affairs, Quality Assurance, Medical Affairs);
- Have the ability to participate in bridging communications between business and safety to ensure appropriate safety context is conveyed.
- Create regulatory reports and analytical papers, gathering and categorizing data, providing initial medical analysis and/or overall benefit/risk.
- Create, or assist in creating:
- PBRERs, DSURs, PADERs;
- Signal detection activities;
- Create and/or review safety portions of submission documents.
- Physician with relevant, hands on safety experience.
- At least 3 years of hands on PV experience in clinical and/or post marketing.
- Solid understanding of regulations impacting Pharma industry in the US and globally, especially drug safety/ PV.
- Hands on experience writing/reviewing Aggregate Reports , e.g., PBRERs, DSURs, and PADERs.
- Hands on experience with signal detection activities such as analyzing/categorizing/ assessing data.
- Strong leadership skills.
- Excellent oral and written communication skills.
- Excellent listening and comprehension skills.
- Ability to work effectively in a matrix setting to resolve issues and achieve common goals.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance