Associate Director, Global Pv Operations - Job Id: Gpv

Ascendis Pharma

7+ years

Not Disclosed

Palo Alto

10 March 19, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Director, Global Pharmacovigilance Operations
Location: [Insert Location]

Company Overview:

Ascendis Pharma is a rapidly growing global biopharmaceutical company with a presence in Denmark, Europe, and the United States. Our mission is to develop new, potentially best-in-class therapies that address unmet medical needs, with a strong focus on Endocrinology, Rare Diseases, and Oncology. At Ascendis, we pride ourselves on exceptional science, visionary leadership, and a team of skilled and passionate professionals.

We foster a dynamic workplace where professionals can make their mark, offering opportunities to grow, develop skills, and contribute meaningfully to advancing healthcare.

Key Responsibilities:

Study Management Support: Act as an active member of Study Management Teams (SMTs) representing the PV Operations team, supporting both Sponsored and Investigator Initiated Trials.
Review Study Documents: Review key study documents such as Study Protocols, Safety Management Plans (SMPs), Data Management Plans, etc.
SAE Reconciliation: Support SAE reconciliation activities for assigned studies as needed.
Study Classification: Oversee study classification, including interventional, non-interventional, and Post Approval Safety Studies (PASS).
PV Vendor Oversight: Ensure PV vendors/service providers meet their responsibilities, ensuring adherence to global/local regulatory requirements and Ascendis policies.
Case Processing: Provide expertise and strategic input regarding the processing of Individual Case Safety Reports (ICSRs) and oversee operational activities related to ICSR processing.
Training & Documentation: Develop training materials (e.g., SOPs) and provide education to internal stakeholders and vendors.
Regulatory Compliance & Reporting: Support the preparation of safety reports (e.g., SUSAR, PSUR, DSUR, etc.) and ensure compliance with pharmacovigilance requirements across vendors and service providers.
Cross-functional Collaboration: Work with Clinical Development, Medical Affairs, and other teams to ensure safety requirements are met for Ascendis products.
Oversight of Patient Support Programs (PSPs): Contribute to the oversight and compliance of PSPs and other service providers.
Crisis Management: Participate in crisis management activities related to pharmacovigilance.
Risk Management Plan Coordination: Coordinate the implementation of risk management plans and associated tracking.

Competencies for Success:

Strong organizational skills and attention to detail in a fast-paced environment.
Demonstrated ownership, initiative, and accountability.
Ability to work independently and collaborate effectively within cross-functional teams.
Excellent communication skills, both verbal and written.
Strong strategic evaluation and decision-making skills.
High level of commitment and adaptability in dynamic situations.

Minimum Qualifications:

Master’s degree in a healthcare field with relevant pharmaceutical industry experience in drug safety.
Minimum of 8 years recent experience in Pharmacovigilance.
Expert knowledge of FDA safety regulations, ICH Guidelines, and global safety regulations.
Ability to travel up to 20% of the time domestically and internationally.

Benefits:

401(k) plan with company match
Medical, dental, and vision plans
Life and AD&D insurance
Short- and long-term disability benefits
Pet insurance and Legal insurance
Employee Assistance Program and Discounts
Professional development support
HSA and FSA options
Incentive compensation plans
Mental health resources
Paid leave for new parents

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Associate Director, Global Pv Operations - Job Id: Gpv

Job Description

Company Overview:

Key Responsibilities:

Competencies for Success:

Minimum Qualifications:

Benefits:

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