Director, Pharmacovigilance and Risk Management Merrimack Pharmaceuticals
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 applies Network Biology, its proprietary systems biology-based approach to biomedical research, throughout the research and development process. Merrimack currently has six targeted therapeutic oncology candidates in clinical development.
Develop pharmacovigilance long-term plan and infrastructure (systems, processes, SOP?s, etc.) to enable full compliance for both internal and partnered responsibilities
Perform clinical assessment of SAE cases reported from clinical trials; perform Sponsor causality assessment; determine regulatory reportability
Work closely with Merrimack colleagues in the proper gathering, evaluation, medical assessment and follow-up of individual case safety reports
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
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
Contribute to and support development of evolving risk management plans
Prepare and maintain summary analyses of safety data on key events from all available sources including the literature
Accurately identify safety issues that require further evaluation and
Effectively collaborate with interdisciplinary team in the evaluation and management of safety issues during clinical development
Contribute to and support safety sections clinical investigator brochures, risk profiles, protocols, and regulatory reports (e.g. Annual IND report; 6-monthly line-listings; EU Annual Safety Report, DSUR)
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 2 years experience in the pharmaceutical, biotech, or contract research organization in Pharmacovigilance & Drug Safety or Pharmacoepidemiology.
Minimum of 1 year 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
Strong analytical skills
Ability to influence others (cross-functionally and within the function) to create a positive working environment
Experience in developing, executing RiskMaps/ Risk Management Plans
Strong commitment to business ethics
Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners
Passion for fighting cancer
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