Shire Manager - Safety Vendor Management in Cambridge, Massachusetts
Primary responsibility is to oversee the quality and compliance of Individual Case Safety Reports (ICSRs) entered into the Shire Global Safety System (SGSS) and to ensure systematic documentation of adverse event (AE) data in the SGSS has been entered in accordance with standard operating procedures (SOPs), work instructions and other Shire trainings and guidances. The incumbent is responsible for Shire's 3rct party case- processing vendor(s) as it relates to quality and compliance of end-to-end case processing activities. Leads initiatives to identify and implement enhancements to improve quality, compliance, productivity and efficiency of case processing activities. Responsible to train and mentor GDS staff on the use of SGSS to ensure consistency and compliance.
- Vendor Oversight : Review case processing quality, coding, seriousness, listedness, causality assessments, narrative writing and overall consistency and provide quality improvement feedback. Monitor vendor timeliness to ensure compliance to company and global regulatory reporting requirements. Serve as the GDS single point of contact for vendor's day-to-day activities and urgently address and/or escalate any issues.
- Quality/Compliance: Ensure the standardization, quality and consistency of ICSRs in support of signal detection activities and aggregate report analysis. Identify and lead efforts to enhance quality compliance, productivity and efficiency of case processing activities by a vendor.
- Training: Support AE case processing training and mentoring of GDS staff, including contractors, to ensure AE data is consistent, standardized and of high quality
- Management: Include but are not limited to, oversight of daily activities, goal setting and performance appraisals of direct reports (if applicable).
- Process Documents: Serve as subject matter expert for the development of SOPs relating to case processing to ensure consistency, standards and compliance to good PV Practices.
Education and Experience Requirements:
Minimum: Bachelor's degree in scientific or healthcare field.
Preferred: BS Nursing, Master's Degree or R.Ph
At least 5 years of drug safety experience in a pharmaceutical company with demonstrable skills in AE case processing activities, including data entry, MedDRA coding, narrative writing, and assessment of reportability
Post-graduate qualification and previous line management experience is desirable.
Prior experience with SharePoint & Master Control desired
Key Skills, Abilities, and Competencies:
Strong clinical and post-marketing adverse event assessment review/documentation skills
Strong knowledge of global clinical safety and pharmacovigilance regulations
Preferred experience preparing and submitting aggregate safety reports
Experience working with quality management processes and compliance monitoring
Solid knowledge of MedDRA terminology and practices
Experience with safety databases (date entry, report generation and ad hoc querying)
Strong attention to detail
Demonstrated ability to work in a fast-paced environment and simultaneously manage multiple competing tasks and demands
Ability to work independently, take initiative and complete tasks to deadlines
Good interpersonal, communication, analytical and organizational skills
Demonstrated ability to motivate, mentor and manage others
Complexity and Problem Solving:
Decisions relating to the management of team members and allocation of workload will be taken On a daily basis. Similarly, assessments of individual team members in terms of quality of work and performance management must be regularly taken.
The GDS Safety Vendor Management manager must have a good understanding of those decisions that need to be referred to senior management. The impact of potential problems may be highly complex and involve active communication in a cross-functional setting to manage various aspects of determining the optimal solution. ·
The GDS Manager, Safety Vendor Management will assess and make recommendations for enhancements for current processes and SOPs to ensure that they are suitable and conform to best practice.
Systems aspects of the role will require requests for enhancements to existing safety database and user requirement testing and participation in project teams.
Internal and External Contacts:
- MentorbestpracticeforcasemanagementandprovideadviceontheapplicationofexistingSOPsandguidelines.RegularlyinteractwithMedical Information andRegulatorystaffonproduct-relatedissuesandsafetyreports.
Other Job Requirements:
- Domestic and International travel may be required (<20%)
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.