Senior Drug Safety Physician

Location: Marlborough, Massachusetts, United States
Salary: US$100 - US$140 per hour + 401k, Medical, Dental, available to enroll
Job Type: Contract
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Job Title:

Senior Drug Safety Physician 11050288

Location:

Marlborough, MA or REMOTE

Duration:

Contract

6 Months

Can Extend

Duties:

The PVRM Physician will be responsible for; the PVRM medical aspects of clinical trials including review/addressing safety queries related to Protocol Informed Consent Form (ICF) Safety Management Plan(SMP) Clinical Study report (CSR) IB safety section etc. Also, the medical review and assessment of individual case safety reports, including seriousness, expectedness, quality of the narratives, adverse event/concomitant medication coding and causality. The PVRM Physician will also provide medical safety subject matter expertise in the review and approval of documents including but not limited to:

* Aggregate safety reports including PSUR, DSUR, PADER.

* Company core data sheets, local approved labels.

* RMP / REMS.

* Regulatory safety inquiries.* IRB / ethics committee safety questions.

* Health hazard assessments.The incumbent will also provide medical safety support for safety signal management throughout product lifecycle including signal detection, validation, development of risk mitigation strategies and authoring of signal evaluation reports.

Skills:

* Thorough knowledge of the pharma industry especially clinical research and global regulatory requirements and experience managing expedited and periodic safety reporting, signal generation, safety evaluation and risk managements strategies.

* Thorough knowledge of FDA and ICH safety reporting regulations and guidelines.

* Demonstrated strategic and critical thinking, strong communication skills (both oral and written).

* CNS, Respiratory, Neurology therapeutic area experience highly desired, but not required.

* Ability to work effectively in teams, strong interpersonal skills and the ability to lead directly or indirectly with influence.

* Strong problem solving, conflict resolution and analytical skills.

7-10 Years of Experience Required

Education:

MD

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