Assoc Prin. Scientist, Drug Safety

Job Description

 

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 in collaboration with the CSRM physician. Leads preparation of responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for assigned products and 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

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.

• Mentors and provides guidance to other medical associates

• 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. May be accountable for the development and maintenance of departmental processes ensuring appropriate cross functional stakeholder engagement on behalf of CSRM.

Education: Physician.

 

Required Experience and Skills:

·       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

 

Preferred Experience and Skills:

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

Required Skills:

Adaptability, Adaptability, Adverse Event Report, Analytical Thinking, Clinical Experience, Competency Management, Computer Literacy, Conflict Management, Critical Thinking, Data Analysis, Detail-Oriented, Drug Safety Surveillance, Employee Training, Global Program Development, Identifying Risks, Information Technology (IT), Lateral Thinking, Leadership Management, Meeting Facilitation, Metrics Development, Organizational Leadership, Pharmacovigilance, Policy Implementation, Product Security, Project Management Leadership {+ 8 more}

Preferred Skills:

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/25/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.