Senior Medical Director, Pharmacovigilance

Categories: Pharmacovigilance
POSITION SUMMARY:

The incumbent will be responsible for global pharmacovigilance for Company’s investigational and/or marketed products assigned to them, including review and analysis of safety data, providing medical expertise to assigned project teams, the identification and investigation of safety signals, management of benefit-risk profile for assigned products and review of aggregate reports. Responsible for keeping upper management informed of safety issues.
 
This is a critical role to ensure safety of patients taking Crinetics investigational and marketed products. May be assigned work of a more complex nature or a global product that is marketed with risk management programs. 
 
 
​ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
  • Maintains expert knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds.
  • Responsible for review of Individual Case Safety Reports (ICSRs). Ensures completeness and accuracy of safety information in ICSR through assessment of seriousness, expectedness, causality, MedDRA coding, review of narrative summary and providing case comments; provide medical inquiries for follow-up.
  • Participates in individual project teams and provides medical input/expertise. 
  • Responsible for safety signal detection activities for assigned products and discuss safety signals as needed at Safety Review Team (SRT).
  • Chairs the SRT for responsible products and works effectively with all cross functional stakeholders (internal and external) to discuss and manages all new emerging safety signals from clinical trials and post marketing environment. 
  • Responsible for contributing and review of aggregate reports (DSUR, PSUR, RMP, ad-hoc safety reports) including but not limited to providing expert medical opinion. Drafts the appropriate safety sections as well as Risk/benefit sections for aggregate safety reports.
  • Support the development and execution of risk management strategies and author internal risk tracking plans and risk management/pharmacovigilance plans for submission to global health authorities for assigned products.
  •  Provides medical opinion and safety input to inquiries from regulatory authorities, IRBs, ethics committees, etc.
  • Establishes good communication and foster relationship with cross boundary stakeholders including PV Vendors, and Crinetics Partners on all pharmacovigilance related issues.
  • Responsible for the maintenance and updating of benefit-risk profile for assigned products through product lifecycle.
  • Contributes and reviews safety sections of study reports, protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA and product labeling.
  • Contributes to the strategy for NDA/MAA filing. Lead or contributes to the components of NDA/MAA dossier.
  • Attends cross functional or project specific team meetings to provide medical expertise, as needed.
 
 
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Performs other tasks and assignments as needed and specified by management
 
 
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
  • MD or DO Degree required; experience with endocrinology or rare disease products is a plus, but not required.
  • Hands-on clinical practice experience is desirable.
  • Experience with NDA/MAA filing is a plus.
  • A minimum of 13 years of Pharmaceutical Industry experience within the Drug Safety Department required, at least 10 of which were spent in a leadership role within pharmacovigilance.
  • Global drug safety experience including depth and seasonality required
  • Extensive knowledge of ICH/FDA guidelines for GCP and Clinical and post-marketing Safety Reporting.
  • Ability to read, analyze and interpret scientific and technical journals.
  • Must have experience in writing/oversight of Annual Reports, DSURs, PSURs, Type II Variations
  • Working knowledge of MedDRA coding and case series retrieval strategies.
  • Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
  • Ability to work with international collaboration partners and CRO’s.
  • Must have very strong English language writing skills and mature verbal communication and presentation skills.
  • Demonstrated decision-making and problem-solving skills coupled with a can-do attitude.
 
 
TECHNICAL KNOWLEDGE REQUIRED: 
Equipment: PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained. 
 
Software Knowledge:  Windows, MS Office (Outlook, Word, Excel, PowerPoint). 
 
 
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities:  On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
 
Laboratory Activities, if applicable:  N/A.
 
 
TRAVEL:
Travel may be required up to 15% of your time.
 
 
The Anticipated Base Salary Range: $250,000.00 – $318,000.00
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown in December.
 
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
 
 
ABOUT CRINETICS:
Crinetics Pharmaceuticals Inc. (www.crinetics.com) is a rare endocrine and endocrine-related cancer therapeutics company. Crinetics’ benefit package includes health insurance, stock options, a 401k, paid time off, and the company provides a dog-friendly work environment.