Associate Director, Global Pv Operations

8+ years

$185,000 - $210,000 per year

Remote, USA

10 Sept. 27, 2024

Job Description

Job Type: Remote 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

Position: Associate Director, Global PV Operations

Reports To: Head of Global PV Operations
Location: [Specify Location]

Job Description:
The Associate Director of Global Pharmacovigilance (PV) Operations is responsible for overseeing all drug safety-related activities for Ascendis’ product portfolio. This role entails collaboration with Study Management Teams and external vendors to ensure compliance with global regulatory requirements and internal policies.

Key Responsibilities:

Support Study Management Teams (SMTs):
- Actively represent the PV Operations team in Sponsored and Investigator Initiated Trials.
- Review essential study documents, including Study Protocols, Safety Management Plans (SMPs), and Data Management Plans.
- Support Serious Adverse Event (SAE) reconciliation activities for assigned studies.
- Classify studies appropriately (e.g., interventional, non-interventional, Post Approval Safety Studies).
Vendor Oversight:
- Oversee PV vendors and service providers to ensure they meet their obligations.
- Serve as a Subject Matter Expert (SME) on Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities.
- Ensure collection, reporting, and handling of adverse events from various sources in accordance with regulatory requirements and company policies.
- Provide guidance and feedback on operational activities related to ICSR processing by PV vendors.
- Develop training materials (e.g., SOPs) for targeted audiences as needed.
- Advise Ascendis Clinical Development, Medical Affairs, and Commercial teams on PV matters.
- Ensure timely ICSR submissions are maintained.
Pharmacovigilance Oversight:
- Manage GVP and Patient Support Programs (PSPs) vendors under the guidance of the Head of Global PV Operations.
- Liaise with functional units to identify Market Research and Patient Support Programs (MAPs) and ensure compliance with PV requirements.
- Maintain oversight of Source Data Quality Check (SDQC) and Case Transmission Verification (CTV) activities.
- Conduct training sessions to enhance awareness of pharmacovigilance requirements.
- Identify compliance risks and develop action plans.
- Support the implementation of Corrective and Preventive Actions (CAPAs) as necessary.
- Collaborate with the GCP/PV Compliance team to ensure effective oversight.
Additional Activities:
- Represent the PV team during regulatory inspections or internal audits.
- Collaborate with the Medical Safety Science team on assigned activities.
- Manage Risk Management Plan implementation and associated tracking.
- Maintain oversight of activities within the PV group under the direction of the Head of Global PV Operations.
- Participate in crisis management activities as needed.

Competencies for Success:

Effective independent and collaborative work style.
Strong organizational skills, detail-oriented, and adaptable in a fast-paced environment.
Demonstrates ownership, initiative, and accountability.
Excellent teamwork and communication skills, both written and verbal.
Strong strategic evaluation, analysis, and decision-making capabilities.
High level of commitment to the organization’s goals.

Requirements:

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

Estimated Compensation: $185,000 - $210,000 per year

Benefits:

Medical, Vision, and Dental Insurance
401(k) Retirement Plan
Paid Maternity and Paternity Leave
Commuter Benefits
Disability Insurance

Ascendis is an equal opportunity employer, committed to fostering an inclusive environment for all employees.

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Associate Director, Global Pv Operations

Job Description

Position: Associate Director, Global PV Operations

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