Pharmacovigilance Scientist Job

PHARMACOVIGILANCE SCIENTIST needed for a CONTRACT opportunity with Yoh's client located in Gaithersburg, MD

TOP SKILLS SHOULD YOU POSSESS:

- Patient Safety

WHAT YOU'LL BE DOING:

- SAFETY GOVERNANCE AND RISK MANAGEMENT ACTIVITIES
- Working with the Global Safety Physician (GSP), support the Clinical Safety strategy for assigned drug projects and products throughout all stages of development and/or when on the market, including supporting the implementation and communication of the safety strategy at the project team/governance level. The strategy includes, but is not limited to: definition of identified and potential risks with high level mitigation and minimization; Instructions of operation of mitigation and minimization into trials; Safety Go-No Go criteria for the clinical program; Safety input to TPP/TPC; An integrated pre-clinical and clinical safety view; Outline of the safety database to launch, Safety submission strategies; the risk component of the benefit/risk assessment.
- Supports proactive pharmacovigilance and risk management planning for designated products, including project managing preparation of the safety aspects of the global Risk Management Plans, in partnership with the Global Safety Physician (GSP) and senior clinical team physician.
- In partnership with the GSP, provides the clinical safety input into Clinical Development planning activities.
- May represent PS on cross-functional Clinical Teams and/or Project Teams for developmental compounds and/or marketed products.
- May provide support to cross-functional ad-hoc teams set up to address urgent and important safety issues.
- Reviews and provides technical insight to investigator brochures, protocols, informed consents, final study reports and external data monitoring committee charters.
- SIGNAL DETECTION, EVALUATION AND LABELING
- Runs/supports routine signal detection process in partnership with GSP, for all products in area or responsibility. Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals
- Supports data evaluation and discussion of the results with the Safety Evaluation Review Meeting (SERM) Chair, GSP and other key stakeholders
- Presents on less complex issues to SERM, in partnership with GSP.
- Drafts accurate and fit for purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
- In consultation with the GSP and Clinical representatives, drafts the Developmental Core Safety Information (DCSI) for assigned development products; co-ordinates meetings and tracks timelines to ensure completion.
- In conjunction with the safety physician, supports evaluation of the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to establish the safety profile of our drugs and manage the risk to patients.
- REGULATORY REPORTS AND SUBMISSIONS
- Authors/provides scientific input to periodic regulatory documents (eg PBRERs, PSURs, and DSURs) according to the agreed process and timelines.
- Drafts/provides scientific input to the patient safety contributions for global regulatory submissions for new products, formulations or indications (NDA, BLA, MAA), in partnership with the GSP and liaison with other functional experts (eg Clinical, Pre-Clinical, Regulatory)

WHAT YOU NEED TO BRING TO THE TABLE:

- A life sciences/pharmacy/nursing degree
- MSc/PhD in scientific discipline preferred
- Fluent in English
- Computer literate
- Foundation understanding of Patient Safety regulatory obligations
- Proven good communication skills with ability to work across cultures
- Able to influence whilst maintaining independent and objective views
- A understanding of how their role within the function contributes to the overall business

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. If you are an individual with a disability and you require an accommodation in the application process, please email.

J2W: CLINICAL

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