The Director, Pharmacovigilance, is a position of vital importance to Adamas. The principal responsibility of the Director of Pharmacovigilance is to ensure the safety of patients taking an Adamas pharmaceutical product. The position is supervised by the Vice President of Pharmacovigilance. The Director of Pharmacovigilance must have the equivalent of a BS, or higher, degree in a health-related field of study (e.g., biology, chemistry, nursing) and more than 5 years post-marketing pharmacovigilance experience. This position will report to the Senior Vice President, Clinical Research, and is based in Emeryville, CA.

Responsibilities:

  • Knowledgeable of pharmacovigilance industry-standards and best-practices, safety issues relating to neurological diseases, with emphasis on Parkinson’s disease and multiple sclerosis, and on drug reactions in the elderly, as well as on specific safety issues relating to amantadine and/or Gocovri;
  • Participates as a core member of the Product Safety Team (PST);
  • Participates in signal detection process;
  • Partners with pharmacovigilance service provider (PSP) in assessment of initial case information, ensuring appropriate assignment of:
    • Spontaneous or solicited case,
    • MedDRA adverse event terms,
    • Expectedness,
    • Seriousness,
    • Potential causal association to product for SAEs
    • Expedited (15-Day) or other level of reportability
    • Pace/prioritization of follow-up
    • Specific follow-up questions
  • Reviews information obtained from PSP outreach to patients, consumers, HCPs and assess for completeness and appropriateness of follow-up case information;
  • Reviews case narratives generated by PSP for completeness, accuracy, and appropriate contextualization vis-à-vis the disease state (e.g., Parkinson’s disease) and drug (e.g., Gocovri);
  • Reviews medical records obtained pertaining to cases;
  • Performs outreach to patients, consumers, and/or HCPs to obtain follow-up information on complex cases;
  • Drafts company comments for SAEs and other select cases;
  • Liaises with medical reviewer;
  • Liaises with specialty pharmacy for clarification of initial AE reports, as needed;
  • Reviews SAEs from clinical trials that have the potential also to be submitted to the NDA
  • Participates in training on safety reporting for Adamas employees and all relevant contractors and service providers;
  • Provides initial review of literature for potential reportable cases;
  • Supervises and mentor manager level PV team members; provide backup, as needed;
  • Participates in preparation and review of aggregate post-marketing safety reports (e.g., PADERs) to FDA and any other relevant regulatory authorities;
  • Additional pharmacovigilance duties as required;
  • Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations.

Qualifications:

  • Required a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline with demonstrated experience with the responsibilities, deliverables, and skills required for this level;
  • Extensive experience (at least 5 years) in pharmacovigilance is required;
  • Demonstrates proficiency in oral and written communication;
  • Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines;
  • Able to work independently, establishing work priorities and direction;
  • Demonstrates excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications;
  • Sufficient skill and confidence to make significant contributions to strategic planning within the pharmacovigilance and epidemiology department;
  • Demonstrates good understanding of observational studies used in pharmacoepidemiology and ability to provide a sound critique of such studies;
  • Successful experience in fast-paced entrepreneurial environment;
  • Fit with Adamas culture and values;

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