Pharmacovigilance and Risk Management Merrimack Pharmaceuticals
THIS JOB HAS EXPIRED Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack currently has six targeted therapeutic oncology candidates in clinical development. The lead candidate, MM-398, which Merrimack is planning to commercially manufacture and sell, is currently in Phase 3 clinical development.
We are seeking a talented Pharmacovigilance and Risk Management leader to join our team. The ideal candidate will have the ability to operate independently in a fast-paced environment and work proactively with various teams across the organization.
Be a key contributor in developing the pharmacovigilance long-term plan and infrastructure (systems, processes, SOP?s, etc.) to enable full compliance for both internal and partnered responsibilities
Work closely with Merrimack colleagues in the proper gathering, evaluation, medical assessment and follow-up of individual case safety reports
Perform clinical assessment of SAE cases reported from clinical trials; perform Sponsor causality assessment; determine regulatory reportability
Perform review of adverse event, medical history and concomitant medication coding into WHO-Drug and MedDRA codes
Prepare/review aggregate safety reports for submission to domestic and international regulatory authorities. Accurately identify safety issues that require further evaluation
Identify and analyze possible trends and concerns with company products including the identification and evaluation of safety signals through the assessment of single case safety reports, aggregate trend analyses and review of relevant literature for safety information pertinent to product safety
Contribute to and support safety sections of clinical investigator brochures, risk profiles, protocols, and regulatory reports (e.g. Annual IND report; 6-monthly line-listings; EU Annual Safety Report, DSUR)
Contribute to and support development of evolving risk management plans
Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the organization
MD, PhD, or PharmD
Minimum of 10 years? experience in a pharmaceutical, biotech, or contract research organization in Pharmacovigilance & Drug Safety or Pharmacoepidemiology
Minimum of 2 years clinical experience in academic or private practice including hospital based setting
Advanced knowledge in pre and post-marketing, US and international, safety regulations
Ability to formulate and lead and investigative plan as well as develop sound risk assessment
Advanced ability to analyze and interpret clinical data
Experience in developing, executing RiskMaps/ Risk Management Plans.
Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners
Strong analytical skills
Ability to influence others (cross-functionally and within the function) to create a positive working environment
Strong commitment to business ethics
Passion for fighting cancer
||One Kendall Square |
Building 700, Second Floor
Cambridge, MA 02139
THIS JOB HAS EXPIRED