Career Developers, Inc.
Principal Safety Scientist - PVRM
|Post Date:||Jan 03, 2018||Type:||Full-Time|
|Start Date:||1/3/2018||Salary:|| |
|Location:||US-NJ-Fort Lee, NJ
REQUIRED EDUCATION & EXPERIENCE
- MS or PhD in Medical Science, Pharmacy or Nursing is REQUIRED
- Minimum of 4-6 years in a pharmaceutical organization or related industry with a minimum of 2-3 years pharmaceutical experience in a clinical safety or regulatory affairs departments required.
- Minimum of 2-3 years of medical writing experience (Prefer experience in writing pharmaceutical reports such as PSURs, Clinical Study Reports, safety sections of the ISS and/or Common Technical Document, or white paper) and/or experience in Medical Surveillance and Risk Management.
- Proven understanding of clinical disease state and implications of treatment.
- At ease with data and statistics.
- Proven ability to communicate effectively (verbal, presentation at group meetings, etc).
- Proven experience with project management (formal or informal).
- Strategic thinking, organizational leadership, results-oriented performance, team player.
- Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with worldwide safety reporting regulations and guidelines) and Risk Management.
- Excellent interpersonal skills, including the ability to work effectively, cross-culturally and cross functionally.
- Excellent written and verbal communication.
PRINCIPAL SAFETY SCIENTIST, PVRM
The Principal Safety Scientist reports to the Medical Leader as part of a team that performs high quality and timely scientific and operational analysis of pharmacovigilance information. This position works closely with the Safety Systems & Information Management and Strategic Alliance, Compliance & Training groups as part of a matrix team to support the Therapeutic Area business unit by ensuring that pre- and post-marketed products are adequately supported from a safety standpoint.
In conjunction with Medical Director, perform safety surveillance activities within a product(s) team that include:
1. Signal Detection and Medical Surveillance Activities
a. Independently evaluates data, identifies opportunities and risks, weighs alternatives and presents analyses to Medical Director for review.
b. Organize planned and ad hoc safety review activities - Obtain data for signal assessment (e.g., Oracle AERS, FDA AERS data, literature search); generate/request listings, identify cases, prepare initial assessment for review and finalization by Medical Director, follow-up on meeting outcome (as needed), ensure the appropriate maintenance of relevant documentation
c. Quarterly AE Review of Clinical Trials - Perform first iteration of listings review, discuss issues with Medical Director
d. Lot Review - Prepare listing and table for Medical Director review and summary
e. Literature Surveillance - Perform review of literature with appropriate documentation; identify case reports as well as new safety information and alert Medical Directors, as appropriate
2. Risk Management/Post-Approval Commitments
a. Under supervision of the Medical Director, contribute to creation, annual review and update of RMPs as needed.
b. Follows up on safety related post-approval regulatory commitments for assigned products
3. Aggregate Reports
•Draft/Collect Sections 1 through 8
•Work with others to determine topics for discussion in Section 9; prepare first draft of Section 9 for Medical Director review
•Follow-up on issues identified in regulatory responses (e.g., assessment reports)
b. US Periodic Reports – Obtain data and develop first draft
4. Clinical Trial Support
a. Oversee and perform case processing activities working with CTSA to ensure consistency, as needed
b. Investigator Brochure (IB): Contribute to creation, review and updates of IB
c. Aggregate Reports for investigational products such as DSURs, ASRs, IND Annual - collect, collate, format and draft PVRM data contribution
d. IND Safety reports - analysis of similar events - Collect, collate, format and draft data contribution and perform first review
e. Database Lock - Perform reconciliation and signoff
5. Regulatory 10 % of Time
a. Regulatory Requests/Responses - Pull data and draft response in consultation with Medical Director prior to management review
b. Submissions - Contribute to creation and review of 2.5, 2.7.4 of CTD; Integrated Summary of Safety; proposed labels for submissions
c. Manage pharmacovigilance related activities associated with proposed safety label changes
a. Effectively manages department workload and product responsibilities.
b. Manage respective outputs for assigned product(s) ensuring on-time delivery of quality documents. Ensures timely decision-making, problem solving, follow through and appropriate managerial elevation of issues.
c. Represents functional area on routine issues and facilitates multidisciplinary communications
Career Developers, Inc.
Name: Kathy Guerra
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