Director, Drug Safety & Pharmacovigilance in San Diego, CA

$150K - $200K(Ladders Estimates)

Halozyme Therapeutics, Inc   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech

  •  

Less than 5 years

Posted 43 days ago

POSITION SUMMARY:

The Director, Drug Safety & Pharmacovigilance will provide expert, data driven medical guidance and decision-making to Halozyme's drug portfolio as an integral cross-functional team member. He/She will be acknowledged as a safety expert by leading safety discussions and applying deep pharmacovigilance expertise to ensure proactive and timely risk assessments of safety data to characterize the emerging and known safety profile of assigned products in Halozyme's drug portfolio. He/She will ensure successful implementation, execution and maintenance of safety-related strategies, processes and systems that conform to the company's business strategy, industry standards and compliance with global regulations. In addition, the Director will contribute to the overall medical oversight and safety evaluation within the drug safety and function for incoming safety reports for all Halozyme investigational and marketed products.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:


  • Identify, analyze and report possible trends and concerns for assigned Halozyme product(s), including the identification and evaluation of safety signals through the assessment of single case safety reports, aggregate data, trend analyses, non-clinical data and review of relevant literature for safety information pertinent to product safety
  • Provide strategic safety input into the ongoing and planned development programs for the assigned product and ensure the accuracy of any developed documents in association with such programs (including protocol, informed consent, statistical analysis plan, investigator brochure, clinical study report)
  • Create and maintain a risk management framework for the assigned product and ensure that the strategy outlined in the risk management plan is executed across safety deliverables for that product
  • As the safety lead for assigned products, lead safety discussions in cross-functional team meetings, resolve differences of opinion and escalate lack of team alignment on safety issues to line management and appropriate governance
  • Perform product risk/benefit or health hazard analysis and assessment to guide appropriate regulatory actions for drug safety and/or quality issues
  • Generate, author, and/or review product safety reports as required by the worldwide regulatory agencies by developing relevant safety data retrieval strategies and evaluating the significance of relevant safety information in collaboration with other functions
  • Participate in multidisciplinary product labeling discussions for updates to core data sheet and local product labels for assigned products
  • Prepare/review of medical safety documents (i.e., periodic safety reports, annual reports, periodic safety updates, safety signal work-ups, risk management plans, risk-benefit assessments, etc.) for assigned product
  • Perform individual case safety assessments of causality, expectedness and seriousness of assigned reported clinical trial and post-marketing safety reports, and clinically approve all potential expedited reports to global health authorities, as assigned

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:


  • Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:


  • Minimum MD with at least 2 years' experience in the pharmaceutical industry performing pharmacovigilance and safety activities (an equivalent combination of experience and education may be considered)
  • At least 2 years of prior clinical or medical practice experience is required
  • Proven experience preparing clinical/regulatory documents and strong analytical, assessment and problem-solving skills
  • Demonstrated knowledge of relevant FDA, EU and ICH guidelines
  • Working knowledge of drug safety databases, such as ARGUS and MedDRA coding
  • Demonstrated ability to read, analyze and interpret clinical data and information
  • Excellent interpersonal skills and professionalism
  • Ability to establish effective working relationships with people in a wide variety of disciplines and backgrounds; manage and prioritize multiple projects and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure
  • MD US board certification and Oncology experience is preferred

TECHNICAL KNOWLEDGE REQUIRED:

Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: N/A

Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: Oracle ARGUS knowledge, and MedDRA coding

INTERNAL AND EXTERNAL RELATIONSHIPS:


  • Close multifunctional department contact with regulatory/clinical/product quality/patient support program team members/global drug safety
  • Consumers, healthcare professionals, healthcare organizations, physicians, clinics, vendors, call centers, FDA and other regulatory bodies

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. Some walking and lifting up to 10 lbs. may be required. The noise level in the work environment is usually low to moderate. 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: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.


Valid Through: 2019-10-2