Drug Safety Physician III
Location: Ridgefield, CT
Contract: 12 months
Title: Drug Safety Physician III
- Duties: Must have experience with review and interpretation of aggregate data, signal management, and optimally with authoring regulatory responses and PV-related documents. In addition to reviewing and interpreting aggregate data, may be responsible for assessing individual case reports for medical review and determining regulatory reporting responsibilities; assessing seriousness, expectedness and causality; and querying for additional medical information needed to understand the event and determine causality.
- Skills: Experience with complex PV analyses and authoring PV-related regulatory documents required. Three years industry pharmacovigilance/risk managment and aggregate analysis of safety data Clinical Medicine experience with more than one year of patient care. Excellent written & verbal communication skills.
Additional information about the job:
- Contractor must have an MD (or equivalent degree)
- This role is not fully independent - you would be reporting to an FTE in a Senior PV Risk Management position.
- Work schedule: 40 hrs a week. Consultant needs to be onsite at some points, and could be negotiated for offsite after a reasonable level of comfort and trust has been built, as the team has flexible work schedules.
- This role is ideal for someone with a more scientific mind. Tasks will include: Aggregate data review, Safety surveillance and signal detection.
- You do not currently need to have a license to practice: However, you ideally will have practiced as an MD and handled safety data, as this role requires medical acumen, and this role would be suited to someone who has taken on patients in the past.
Nice to have skills:
- The more experience you have in surveillance the better. Writing documents such as PSURs is a preferred skill but not necessary. Experience with ArisG or Argus is helpful.
Sthree US is acting as an Employment Business in relation to this vacancy.