Clinical Safety and Risk Management Associate Principal Scientist Full-time

Clinical Safety And Risk Management Medical Associate Principal Scientist

The Clinical Safety and Risk Management Medical Associate Principal Scientist performs primary medical review of serious adverse experience (AE) reports and other AE reports of interest in order to monitor and describe the safety profile of assigned products.

Takes an active role in the oversight and development of pharmacovigilance and risk management plans (RMPs) of assigned products under the direction/guidance of the CSRM physician.

Assists the CSRM physician to prepare responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for assigned products.

In collaboration with the CSRM physician, strategizes with the Risk Management Safety Team (RMST) recommending appropriate data to respond to queries and analyze data.

Primary activities include, but are not limited to:

• Applies clinical, pharmacological, and epidemiologic knowledge and information technology (IT) skills in order to manage the safety surveillance and risk management of assigned products in collaboration with the CSRM physician
• In collaboration with the CSRM physician, accountable for monitoring the overall safety profile of assigned products and for describing the safety profile to ensure external communications regarding the safety of these products are accurate
• Performs safety surveillance review of adverse experience reports for assigned products which includes reviewing individual AE reports, aggregate safety data, published literature, and information from external databases
• Works with CSRM physician to select and analyze the appropriate data from available IT systems in order to investigate safety issues
• Prepares responses to safety inquiries from health care professionals, regulatory agencies, subsidiary staff, and other internal customers
• Demonstrates a working knowledge of pharmacovigilance and risk management; may educate stakeholders outside of CSRM about risk management and the role of CSRM
• Prepares summaries and analyses of safety related data for regulatory documents such as Periodic Safety Update Reports (PSURs), Developmental Safety Update Reports (DSURs) and summaries in support of regulatory filings
• Core member of RMST; represents CSRM on cross-functional teams and committees as appropriate. Assists the RMST with the development, maintenance, and monitoring of RMPs and Risk Evaluation and Mitigation Strategies (REMS) for assigned products
• Participates in the development, implementation and evaluation of standards, processes, metrics, and other department initiatives.

Qualifications, Skills and Experience:

• At least two years of clinical experience in a patient care setting is required
• Minimum 5 years of professional experience with both clinical and pharmaceutical industry experience required, of which a minimum of 2 years MUST include safety experience (e.g. PV or clinical) involving causality assessment, analysis of aggregate safety data and/or authoring of safety documents.
• Experience in drug safety, pharmacovigilance and/or risk management
• Excellent writing and communication skills in English
• Demonstrated leadership skills in managing programs, processes, and facilitating meetings
• Effective presentation skills and experience influencing and negotiating
• Computer skills – use of database and basic MS Office suite applications
• Problem solving, conflict resolution and critical thinking skills
• Candidates without prior pharmaceutical industry experience are welcome to apply and may be considered for a more junior entry level.

Preferred Experience and Skills:

• Subject matter expertise in specific departmental programs, SOPS, and departmental initiatives.

Education:

• Medical Doctor (MD)

Required Skills:

Adaptability, Audit Process Evaluations, Clinical Judgment, Compliance Program Development, Critical Thinking, Data Analysis, Decision Making, Detail-Oriented, Drug Safety Surveillance, Epidemiology, Ethical Compliance, Medical Writing, Periodic Safety Update Reports, Pharmacodynamics, Pharmacognosy, Pharmacotherapeutics, Pharmacotherapy, Pharmacovigilance, Post Marketing Surveillance, Problem Solving, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Risk Management

Preferred Skills: