Sr. Spclst, Drug Safety

Job Description

The Senior Specialist within the PV-operations Clinical Safety Strategy Operations team collaborates with MRL colleagues to provide operational and regulatory pharmacovigilance (PV) input for company processes and standards and software system configuration that impact trial adverse event (AE) reporting and management. Maintains PV global standards for relevant activities to ensure compliance and quality aligned with SDLC (software development lifecycle) ICH/GCP International Conference on Harmonization/Good Clinical Practice) and PV requirements. The Senior Specialist stays current on existing and emerging SDLC, ICH/GCP, and PV regulations and guidance.

This position will focus on the development and maintenance of the Label Validation Files. The Label Validation File contains adverse event (AE) terms that are considered expected (or referred to as “labeled”) for a product and is created from the Reference Safety Information (RSI). The RSI is used to determine regulatory reporting requirements of an adverse reaction. The LVF is incorporated into the regulatory safety system and enables the expedited reporting of cases that are suspected unexpected serious adverse reactions (SUSARs). The maintenance of the LVF includes creating and updating company and non-company products, MedDRA Upgrades, and ad-Hoc requests. The role collaborates cross-functionally to understand the study configuration, check document readiness, submission to health authorities, and local country pharmacovigilance.

**Key Responsibilities**:
Creation and Maintenance of Label Validation Files

Cross-functional collaboration with key customers in GCS&PV such as Clinical Safety & Risk Management (CSRM), Medical Safety Review (MSR) & PV-O&GPE (PV-Operations & Global Process Enablement); and Global Clinical Trial Operations (GCTO), in support of end-to-end creation and maintenance of Label Validation Files

Represent CSSO on cross-functional teams and strategic initiatives

Participate in interdepartmental and interdivisional meetings to support Label Validation Files and provide input for operational and regulatory PV requirements, and related processes

Participate in cross-functional meetings to support the development of data collection deliverables

Collaborate with external colleagues, business partners, and vendors as needed

Support the development/update of process documents

Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits as applicable

**Education**:
**Required**: Bachelor's degree or master's degree in a life science/health care/pharmaceutical related field or MD/DO/International equivalent

A minimum 3 years of work experience in pharmaceutical, clinical drug development, and/or drug safety experience required

**Preferred**:
Medical degree/DO/International equivalent with clinical experience

**Required Skills**:
Basic understanding of drug development

Basic knowledge of ICH, GCP, and PV regulations

Experience working as part of a cross-functional team setting

Effective problem-solving skills, can analyze an issue and develop and implement solutions with oversight

Project management, and time management/organizational skills

Plans and coordinates work activities with others to maximize results

Proactively seeks out advice and information from others when addressing business issues

Strong communication skills with advanced oral and written English skills

Strong computer and database skills, experience working with Microsoft Office tools

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**: R231861