Medical Director, Pharmacovigilance
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Job Location:
Waltham, MA - USA
Monthly Salary:
$ 240000 - 320000
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
Description
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Position Summary:
Medical Director Pharmacovigilance (PV) leads product safety strategy overseeing risk management signal detection and regulatory compliance from clinical development through post-market serving as the medical safety expert managing PV operations guiding safety document authoring and collaborating cross-functionally to ensure safe and effective product use.
Responsibilities:
- Serve as Global Safety Lead (GSL) and the safety expert for assigned pharmaceutical products accountable for the safety strategy and major safety deliverables for each assigned product
- Lead the Safety Management Team (SMT) for assigned compounds and products and represents the cross functional program team as a product safety profile and risk mitigation expert for internal and external stakeholders
- Analyze and interpret safety data from various sources including non-clinical clinical post-marketing and scientific literature for assessment of benefit-risk profile and updating of the benefit-risk documents e.g. RMPs for assigned compounds and products
- Conduct signal detection monitoring evaluation interpretation and management for assigned compounds and products
- Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees
- Provide medical safety expertise medical interpretation review and authorship of appropriate sections for critical documents (e.g. protocols and amendments ICFs IBs clinical research reports Health Hazard Evaluations Signal Evaluation Reports INDs NDAs and CTAs) in collaboration with cross-functional colleagues
- Provide patient safety input to the clinical development program for assigned products and development compounds and represent PV on internal governance bodies for study protocols statistical analysis plans and other clinical study-related documents as applicable
- Collaborate and communicate safety issues with other functional areas such as Clinical Development Regulatory Affairs Biometrics Quality Assurance Medical Affairs Marketing Manufacturing and Legal
- Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure as well as other labeling documents
- Up to 10% of domestic travel to attend meetings
Qualifications:
- Doctor of Medicine (M.D.) with 8 years of pharmacovigilance drug safety or related experience or equivalent experience
- Extensive experience in evaluating signal detection activities and analyzing safety data identify trends and detect new or emerging safety signals
- Ability to analyze using statistical methodologies (e.g. disproportionality analysis) to assess potential safety concerns and evaluate the frequency and severity of adverse events
- Proven strategic mindset to analyze information to strategize recommend and develop risk management plans
- Advanced analytical skills to evaluate and develop periodic safety reports including Periodic Benefit Risk Evaluation Reports (PBRER) Developmental Safety Update Reports (DSURs) and Periodic Adverse Drug Experience Reports
- Proven ability to utilize MedDRA and assign appropriate MedDRA terms to describe adverse events and WHO DD dictionary coding to accurately capture and standardize information related to medicinal products
- Experienced in designing and implementing strategic safety and personnel development as required
The anticipated annualized base pay range for this full-time position is $240000-$320000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors including years of relevant experience training qualifications and internal equity. The compensation package may also include an annual bonus target and equity awards subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees including a 401(k) plan with generous employer match 12 weeks of paid parental leave up to 12 weeks of living organ and bone marrow leave equity incentive plans health plans (medical prescription drug dental and vision)life insurance and disability flexible time off annual Winter Holiday shut down and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
Required Experience:
Director
Key Skills
- EMR Systems
- Post Residency Experience
- Occupational Health Experience
- Clinical Research
- Managed Care
- Primary Care Experience
- Medical Management
- Utilization Management
- Clinical Development
- Clinical Trials
- Leadership Experience
- Medicare
About Company
From discovery through commercialisation, all of us at Ardelyx are driven to advance targeted therapies where significant medical needs persist.
