Medical Director, Pharmacovigilance

Ardelyx

Waltham, MA

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JOB DETAILS

SALARY

$240,000–$320,000 Per Year

JOB TYPE

Full-time

SKILLS

Adverse Events, Analysis Skills, Biometrics, Biotech and Pharmaceutical, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Cross-Functional, Data Analysis, Datasheets, Drug Development, Employee Benefits, Functional Programming Languages, Health Plan, Incentive Programs, Insurance, Legal, Manufacturing, Marketing, Medical Affairs, Medical Dictionary for Regulatory Activities (MedDRA), Medical Ethics, Medicine, New Drug Application, Operations Management, Patient Safety, Pharmacovigilance, Prescription Drugs, Product Programs, Product Safety, Product Strategy, Quality Assurance, Regulations, Regulatory Compliance, Research Protocols, Risk, Risk Analysis, Risk Management, Safety/Work Safety, Staff Development, Statistics, Strategic Analysis, Strategic Planning, Surface Mount Technology, Team Player, Trend Analysis, Willing to Travel

LOCATION

Waltham, MA

POSTED

27 days ago

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive. We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve.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 experienceExtensive experience in evaluating signal detection activities and analyzing safety data, identify trends, and detect new or emerging safety signalsAbility to analyze using statistical methodologies (e.g., disproportionality analysis) to assess potential safety concerns and evaluate the frequency and severity of adverse eventsProven strategic mindset to analyze information to strategize, recommend, and develop risk management plansAdvanced 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 ReportsProven 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 productsExperienced in designing and implementing strategic, safety and personnel development as requiredThe anticipated annualized base pay range for this full-time position is $240,000-$320,000. 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.

About the Company

Ardelyx

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