Associate Director, Signal Management and Innovation

Lancesoft; Cambridge (MA); On-site; USD 110,000 - 135,000; Full time

Job summary

Lancesoft is seeking a senior Pharmacovigilance professional to lead signal detection and management, ensuring compliance with global health authority expectations. The role involves cross-functional collaboration with Global Regulatory Affairs and Data Sciences, and delivering targeted trainings to PSPV teams.

The ideal candidate will have a health care or life sciences background, excellent communication and analytical skills, and the ability to present complex data clearly at a global level.

Qualifications

• Health care background or life science degree required.
• Excellent document creation skills.
• Global regulatory affairs understanding desirable.

Responsibilities

• Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations.
• Lead interactions with PSPV and other functions to ensure standards are maintained.
• Represent pharmacovigilance as subject matter expert in cross-functional teams and external environments globally.
• Design and deliver relevant training.
• Provide mentorship for junior/new pharmacovigilance scientists.
• Conduct project activities for designated processes.
• Handle vendor oversight of signal management activities.

Skills

Excellent communication

Critical thinking

Presentation skills

Document creation

Education

Bachelor's degree in life sciences

Tools

MS Office

Job description

Objective / Purpose:

Describe at the highest level the team where this job sits and how this role will contribute to the team s delivery of critical functions. Ensures signal detection, evaluation and management processes meet highest standards by working cross functionally and leading the development of required processes (eg with Global Regulatory Affairs, Data Sciences). Ensures that client Signal Management processes and activities are compliant with Global Health Authority expectations, including EU regulations and EU regulatory authority and inspectors expectations. Represents Pharmacovigilance and client externally at a global level as an authoritative expert on signal detection processes. Leads training for PSPV and other relevant functions on signal detection processes to ensure training and compliance with processes are maintained. Leads interactions with other PSPV functions including EU QPPV and Global Medical Safety to ensure processes are regularly updated and are fit for purpose. Leads interactions and oversight of signal management activities conducted by any vendor.

Accountabilities:

Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 10 bulleted task statements should be identified. Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations and in close liaison with the business units, including Data Sciences as well as internal PSPV stakeholders. Leads interactions with other relevant functional areas both within and outside of GPSE to ensure standards are maintained. Represents the pharmacovigilance department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required. Designs and delivers relevant training as appropriate. Provides mentorship and guidance for junior/new pharmacovigilance scientists and others as appropriate. Conduct project activities for designated processes. Any other tasks assigned by manager to assist in related departmental activities.

Education & Competencies (Technical and Behavioral):

List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted. Health care background or life science degree/Bachelors required;degree in life sciences preferred Excellent document creation skills In depth knowledge and experience of clinical trial methodology, pharmacovigilance regulations, signal detection and risk/benefit analysis Critical, strategic thinking and decision-making skills Ability to review, analyze, interpret and present complex data to a high standard Global player in a PV organization with the ability to adapt to change Excellent communication and presentation skills Good level of computer literacy Excellent organization skills and ability to prioritize