Job Description Summary

Job Description

ESSENTIAL FUNCTIONS:

1.       Perform and/or review medical assessment of individual case safety reports including seriousness, expectedness/listedness, causality and determination of additional follow up for both post-marketing surveillance and clinical studies.

2.       Author and/or review and approve all aggregate safety reports including Periodic Adverse Drug Experience Report (PADER), Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR), Risk Management Plan (RMP)/ Risk Evaluation and Mitigation Strategy (REMS), and response documents to safety inquiries from world-wide regulatory agencies.

3.       Responsible for safety aspects of clinical trials including evaluation and interpretation of appropriateness of safety monitoring and information collection in protocol and case report form, company/sponsor evaluation on individual Adverse Event (AE) reports, safety findings for Investigational Brochure, clinical study reports, summary of clinical safety, risk and benefit assessments and product labeling in regulatory submissions.

4.       Lead safety signal management throughout product lifecycle including signal detection, evaluation, validation and development of risk management strategies.  A GSL takes the initiative to evaluate all safety triggers and thresholds and potential safety signals resulting from both quantitative and qualitative methods. Prioritize signals according to public health impact then evaluate them in timely fashion. This includes the following:

A.      Comprehensive review of all available safety data including current and historical medical and scientific literature, the global safety database and relevant clinical trial data.

B.      Assessment of the causal association between a product-event pair, using current threshold criteria. Safety results are periodically presented and defended before a management review panel (Safety Review Board).

C.      Following approval of signals, the GSL along with Regulatory Affairs will coordinate a Label Working Group to update the United States Prescribing Information (USPI) and/or plan public communication for new safety findings.  If applicable, along with Regulatory Affairs will coordinate the Company Core Safety Information (CCSI) working groups. CCSI WG may update existing CCSI with new safety findings or create a new CCSI. The GSL will develop project plans and timelines to support the Label WG and CCSI WG activities, assist in drafting USPI and CCSI revisions and provide supporting documentation.

5.       Serve as safety expert on inter-departmental teams to assess patient safety impact arising from deviation from product quality specifications by performing Health Hazard Evaluations and by contributing to Corrective Action and Preventative Action Plans (CAPA).

6.       Communicate effectively and timely on safety and benefit/risk assessment, risk analyses, communication, mitigation, and minimization to internal and external stakeholders. Lead or contribute to project and/or process improvements that support overall strategic safety objectives. 

7.       Mentor and support on-boarding trainings of new colleagues. 

8.       Develop and maintain comprehensive and up-to-date knowledge of the assigned product portfolio and regulations for safety reporting and surveillance.

9.       Develop and maintain audit/inspection readiness for GSL function: Assist in internal and external audits/inspections for Medical Safety for pharmaceuticals and medical devices as needed.

MINIMUM REQUIREMENTS:

Education:

Health care professional with post graduate medical qualification (MD/DO or equivalent)

Experience:

1.       A minimum of 5-10 years clinical/practical experience in a relevant clinical environment.

2.       A minimum of 2 years of Pharmacovigilance experience in Clinical Safety or Post-Marketing Safety including thorough knowledge of FDA and ICH safety reporting regulations and guidelines.

3.       Any experience with regional, national and global regulatory authority is a plus.

Preferred Skills/Qualifications:

• Advanced analytical skills

• Sound medical judgment and decision-making capabilities

• Strong oral and written communication skills

• Strategic thinking and facilitative leadership

• Fluent utility of office computer programs such as Excel, Word, and PowerPoint

• Formal training in Epidemiology a plus

• Knowledge of navigating within a drug safety database a plus

• Sound organizational and prioritization skills

• Demonstrated skills for project management

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

·         Sr. Dir, Pharmacovigilance & Risk Management (PVRM)

·         Interact with a variety of Corporate Divisions.  These include, but are not limited to, Legal, Regulatory Affairs, Medical Information, Pharmacovigilance, R&D, Marketing, Quality Assurance, Sales, and Customer Service.  The degree and scope will vary according to the needs of the departments involved

WORKING CONDITIONS:

·         Remote eligible

·         Occasional travel may be required for such things as training seminars, manufacturing site visits, and professional/trade conventions.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.