Medical Director - Pharmacovigilance and Safety
The Judge Group Inc.

Location: REMOTE
Salary: $200,000.00 USD Annually - $260,000.00 USD Annually
Description: Our client is currently seeking a Medical Director - Pharmacovigilance and Safety
The Director Drug Safety and Pharmacovigilance will be a senior leader in the Clinical Development and Medical Affairs organization responsible for leading pharmacovigilance and risk management activities. This is a highly visible role that will interface across all levels of management and functional areas and is responsible for identification of safety signals, signal investigation and proactive management of the benefit-risk profile of company products.

This job will have the following responsibilities:

• Accountable for global oversight of drug safety processes and compliance, and drug safety deliverables. Provides detailed, accurate and timely medical review of aggregate and/or individual clinical trial and post-marketing adverse event reports (AERs)
• Performs signal detection using the medical literature and relevant medical databases, as appropriate.
• Medically reviews individual case study reports from clinical trials, as well as evaluates all relevant cases in depth, including MedDRA coding
• Performs regulatory assessment for expectedness and seriousness of AEs. Oversees the delivery of Periodic Adverse Drug Experience Reports. Accountable for SAE narrative generation; SAE database; and investigator alerts for clinical trials.
• Ensures timely and appropriate drug safety contributions to NDA periodic reports. Oversees the regular review of NDA safety data with respect to safety label updates and modifications. Directs the creation and maintenance of company core safety information.
• Reviews and approves safety sections of all clinical study reports (CSRs) (including interim as well as final reports).
• Oversees the preparation of NDA documents, specifically the Integrated Summary of Safety (ISS) or equivalent document, and all safety related review comments or questions. As needed, Develops and oversees Risk Minimization Plan (RMP) and/or Risk Evaluation and Mitigation Strategy (REMS).
• Collaborates with cross functional team to develop Risk Assessment Plan, with continued monitoring throughout the development and life cycle activities. Oversees development, implementation and reporting of pharmacoepidemiology studies when needed.
• Responsible for the safety agreements with DR&PV vendors and clinical trial CROs. Contributor to key clinical and regulatory documents such as Investigator Brochures (IBs), IND packages, and other safety documents to support CTAs, NDAs or Annual Reports.
• Stays informed of new safety regulations and guidance from the regulatory authorities. Manages pharmacovigilance provider; supports vendor identification and contracting as required.

Qualifications & Requirements:

• Advanced Life Science degree required (PharmD, PhD; MD or DO preferred).
• A minimum 7 years combined in pharmacovigilance and clinical research/clinical safety experience in the pharmaceutical industry.
• Ability to synthesize and analyze safety data from various sources.
• Proficiency in problem-solving within a highly complex environment.
• Knowledgeable in international regulations governing drug safety
• Experience in managing compliance or audits.
• Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing.
• Strong communications skills, both written and spoken, ideally with demonstrable experience in medical / scientific writing.
• Excellent networking and relationship building skills for successful cooperation with internal and external customers.
• Excellent interpersonal skills with the ability to develop important relationships with key stakeholders and influence others.
• Additional Information: Technology needs: Microsoft Office (Word, Excel, PowerPoint and Outlook) and PV platforms and tools (ARUS, Medra).
• Travel requirements (%): 10-15%, as needed

Contact: bchauhan@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

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