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| Safety Science Leader |
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| Job ID |
1000029805 |
| Requisition Number |
09-1000029805 |
| Location |
South San Francisco, CA |
| Job Category |
Drug Devt - BioMedical Sci |
| Shift |
N/A |
| Description |
The Safety Science Leader (SSL) is accountable for all aspects of safety related to early clinical development products including:
* Single cases assessment medical evaluation
* Aggregate reporting.
* Signal Detection.
* Safety Analysis (including monitoring evolving safety profiles).
* Risk Management (including implementing and coordinating safety surveillance procedures).
* Preparing and communicating safety reports
* Serving as the Genentech safety lead to the Development Sub-Team, other multi-functional teams, and business partners
With the development team, the SSL focuses on characterizing the benefit/risk profile of the product to ensure the safety and longevity of products throughout their development lifecycle.
The SSL maintains an Integrated Safety Management Plan (ISMP) throughout the life cycle of the product and is accountable for the safety component of the study protocols and reports, informed consent, investigator's brochure, development core safety information, as well as various periodic safety reports. Ultimately the SSL contributes to the appropriate design of the clinical development plan and facilitates the transition of appropriate drug candidates from exploratory to confirmatory development for all aspects pertinent to safety.
The SSL is also responsible for leading departmental initiatives for the development of pharmacovigilance practices, acting as senior safety representative in company initiatives, and mentoring junior drug safety colleagues.
RESPONSIBILITIES:
* Monitor the safety profile of delegated products and recommend appropriate action including IB/ICF amendments, Investigator/regulatory authority/ EU QPPV communcations, safety surveillance, and risk management programs when warranted.
* Preparation of relevant safety documents. This includes writing detailed safety analyses such as drug safety reports, and periodics, such as the European Annual Safety report (EU ASR). In addition the SSL participates in the preparation of other relevant documents such as Investigational New Drug applications, clinical study reports, Integrated safety management plan (ISMP), development core safety information (DCSI), and filing documents.
* Ensure corporate compliance with international reporting requirements for aggregate safety data regulatory reports for delegated products.
* Act as Genentech safety lead on assigned projects with Development Sub-Teams, Clinical Sub-Teams, business partners on assigned projects, and in interactions with Medical Monitors, Drug Safety Committee, Development Review Committee, and other Genentech personnel.
* Lead cross functional Safety Sub-Teams for assigned products.
* Provide medical input to relevant clinically important adverse event reports.
* Liaise with appropriate departmental management to propose, initiate, and lead intradepartmental initiatives for the development of pharmacovigilance practices, such as signal detection methodologies, medical review practices and formulating safety surveillance policies and procedures, in line with emerging new requirements and regulatory guidance.
* Participate in company initiatives as senior drug safety representative.
* Mentor junior Drug Safety personnel.
REQUIREMENTS:
* MD
* At least 2 years Clinical experience required.
* Medical writing experience required.
* Experience with computers required; computer data entry experience preferred.
* Pharmaceutical industry experience with at least 3 years pharmaceutical industry safety surveillance experience required.
* Knowledge of regulatory adverse event reporting requirements required.
* Management experience preferred.
DIVISION: Development - Medical Affairs
REQUISITION NUMBER: 09-1000029805 |
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