Medical Director, Drug Safety
Chicago - REMOTE
Looking to join a cutting-edge pharma company on the brink of exponential growth? Well look no further! We are looking for a Medical Director, Drug Safety at a rapidly expanding company in the Greater Chicago area. You will monitor medical assessment of individual safety events, signal detection, benefit-risk evaluation, and appropriate risk management activities. While reading this and you thought to yourself "This opportunity is for me!" then please reach out and learn more.
The Medical Director, Drug Safety will be responsible for:
- Conducts medical review and assessment of clinical trial and post-marketing cases for all products, ensuring the case narratives are medically accurate, the events within cases are properly coded and have the proper labeling assessment, and that cases are queried for additional information as needed.
- Authors or contributes to safety sections of regulatory submissions, including New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and responses to regulatory authorities.
- Provides product safety training to internal employees and external contractors / vendors as needed.
- Participates in investigators' meetings to provide training on adverse events reporting as required.
- May prepare and present product safety issues at internal and external meetings.
- Assists in the creation, review and implementation of new Standard Operating Procedures (SOPs), Work Instructions, guidelines, documents and other tools pertaining to the role.
- Reviews all appropriate safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the product development life-cycle to proactively identify any new safety issues that may require further evaluation to determine a causal relationship with products in development or on the market.
- Authors the analysis of similar events (AOSE) for any expedited cases.
- Authors or provides medical review of all aggregate safety reports such as Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Investigational New Drug (IND) Annual reports, and line listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for regulatory submission.
Ideal Candidates will have:
- MD or international equivalent.
- Advanced therapeutic area training.
- 4 years safety and PV experience including a focus in post-approval setting.
- 2 years drug development experience.
- Experience with NDA filing is a plus.