Senior Safety Process Specialist

<h2≥Job Overview:</h2≥<ul≥<li style="color: #000000;"≥Oversee audit and inspection preparedness and conduct pre-audit/inspection dipsticks</li≥<li style="color: #000000;"≥Attended PSS qualification and in-flght study audits</li≥<li style="color: #000000;"≥Mentor/ train new hires and perform periodic retrainings as possible</li≥<li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;"≥Conduct Periodic independent Quality and Compliance project reviews and support effective closure of identified issues/gaps</li≥<li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;"≥Manage departmental Quality issues, CAPA development & implementation (inclusive of internal QEs and those resulting from audits & inspections)</li≥<li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;"≥Support review/update of departmental process guidance documents (SOPs, WIs, job aids, templates etc)</li≥<li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;"≥Support development of responses and CAPA plans for audit and inspection findings</li≥<li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;"≥Perform impact assessment and trend analysis for Quality & compliance</li≥<li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;"≥Support preparation of Departmental compliance dashboards and associated actions</li≥<li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;"≥Initiate, implement and monitor process improvement and departmental compliance initiatives</li≥</ul≥<h2≥Education/Qualifications:</h2≥<ul≥<li style="color: #000000;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Associate degree + 4-5 yrs safety experience*</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Associate degree RN + 4-5 yrs safety experience*</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥BS/BA + 3-4 yrs safety experience*</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥MS/MA + 2-3 yrs relevant experience** (1-2 yrs safety experience)</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥PharmD + 1-2 yrs relevant experience** (1 yr safety experience)</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 10pt; margin-top: 0in; margin-bottom: 0pt;"≥ </li≥</ul≥<p style="margin: 0in 0in 0pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥For PharmD, a one-year residency of fellowship can be considered relevant experience.</span≥</p≥<p style="margin: 0in 0in 0pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥ </span≥</p≥<p style="margin: 0in 0in 0pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.</span≥</p≥<p style="margin: 0in 0in 0pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥ </span≥</p≥<p style="margin: 0in 0in 0pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.</span≥</p≥<p style="margin: 0in 0in 0pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥ </span≥</p≥<p style="margin: 0in 0in 0pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.</span≥</p≥<h2≥Experience:</h2≥<ul≥<li style="color: #000000;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Prior experience handling/ attending audits, developing audit responses - and preparation effetctive CAPAs, etc. </span≥</li≥<li style="color: #000000;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Experience performing review/ assessment of quality of case data, study documents.</span≥</li≥<li style="color: #000000;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥High degree of accuracy with attention to detail.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Functions as a team player.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Ability to present and share useful business information across departments and functions.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Ability to anticipate and identify problems and take appropriate action to correct.</span≥</li≥</ul≥<ul≥<li style="color: #000000;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Knowledge of medical and drug terminology </span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Knowledge of ICH Guidelines</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Knowledge of Medical Device reporting desirable</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Good knowledge and understanding of industry and R&D processes and objectives.</span≥</li≥<li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"≥<span style="font-family: book antiqua,palatino; font-size: 11pt;"≥Ability to work independently with minimal supervision</span≥</li≥</ul≥