Medical Affairs/Safety-Manager, PV (cur_1_129766@curatelyai.net)

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: Medical Affairs/Safety - Manager, PV Scientist

Location:  Cambridge, MA 02147

Duration: 6 Months

Pay rate: $80/hr. - $110/hr.  on W2

Job Description:

Summary of Key Responsibilities:

• Works closely with the safety lead physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
• Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
• Assists in evaluation and development of Safety Management Plans
• Assists in data analysis compilation and presentation at cross-functional meetings.
• Assists in the evaluation of potential safety issues.
• Contributes to activities related to the functioning of Client safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues.
• Contributes to the development and management of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
• Assists in RMP and DRMP development and updates.
• Supports authoring for aggregate safety reports (eg.PSUR, DSUR, Line listings) in close collaboration with the safety product lead and operational functions

Qualifications:

Education:

• Degree in a medical or healthcare related discipline (PharmD, RN, MD) is required

Experience:

• A minimum of five to seven years in the pharmaceutical industry with experience in drug safety/pharmacovigilance. Previous experience in managing drug safety personnel a plus. Specific experience in RNA therapeutic area at a global level is an advantage.

Strong skills and experience in:

• Ability to work in a matrix environment in accordance with the company leadership commitments and values.
• Excellent planning, organization, written and oral communication skills
• Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
• Understanding Signaling tools (eg. Empirica)
• Experience in clinical patient care is a plus
• Regulatory Inspection readiness experience is a plus
• Supervision: Individual is expected to work independently with support from management and colleagues in SRM.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.