DIRECTOR, PHARMACOVIGILANCE @ Aurobindo Pharma USA, Inc. - East Windsor, NJ

Job Overview

8 days ago

DIRECTOR, PHARMACOVIGILANCE

Aurobindo Pharma USA, Inc. - East Windsor, NJ

Division Overview:
Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992.

Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages.

Aurobindo markets over 80% of the top 100 most prescribed products in the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors.

Job Overview:
This role will lead Pharmacovigilance and Quality Complaint oversight including establishing clear key performance indicators, ensuring efficiency in the processes, and ensuring case level quality of the work performed. The candidate will work cross-functionally as needed with key stakeholders and external resources on pharmacovigilance-related matters for business integration activities.

This position reports to the Associate Vice President of Quality Assurance and sits on the East Windsor New Jersey campus.

Responsibilities:
Oversees and manages United States Pharmacovigilance and Quality Assurance Product Complaint Teams.
Oversees and manages PV vendor(s) to ensure regulatory compliance and contractual obligations met
Reviews the safety sections of quality and compliance documents, including the safety portion of protocols, annual reports, investigational brochures, quality agreements (if applicable) and other documents
Reviews safety management plans and associated documents to ensure that study-specific and health authority reporting requirements are met and that workflow between contract research organizations (CROs) and APUSA is delineated
Develops, reviews and updates drug safety forms and templates
Write, review, and approve Safety Data Exchange Agreements (SDEA)
Plans and oversees SAE database reconciliation in collaboration with Data Management
Collaborates with Medical Director, Data Management, and external vendors to obtain necessary data outputs for independent data monitoring committee meetings for all programs
In conjunction with Global Pharmacovigilance Team, ensures timely submission of expedited safety reports to Regulatory Authorities in conjunction with Quality Assurance and / or Regulatory Affairs and / or Contract Service Provider
Assists with training appropriate cross-functional personnel and external groups in drug safety principles and practices
Provide Pharmacovigilance and Current Good Manufacturing Practices (cGMP) training to all PVG and non-PVG new hires within the United States
Ensures compliance with global regulations and ICH guidelines to meet all drug safety and pharmacovigilance reporting requirements
Implements PV quality management system including the identification and authoring of required procedural documents
Interact with the US Head of Quality and Compliance as well as our Parent Division (APL) in India, US Regional Sites and all Subsidiaries to process Field Alerts
Lead and / or support inspections / audits both external (Agency and Customer) and internal as they apply, but are not limited to PVG
Prepare PVG Quality Performance Metrics and Represent the Department in Quality Council Meetings
Support REMS functions for products that require REMS by attending the required meetings and interacting with the third party contractors. Responsible for the generation of department Budget. Primary contact for Pregnancies Exposed to Antiepileptic Agents.
Handling all the Recalls and Market Withdrawals and interacting with FDA by sending them initial Recall material, monthly updates, and recall termination documents.
Responsible per for Pharmacovigilance (RPP) for all Pharmacovigilance activities in the United States

Qualifications - Skills & Requirements:
Solid knowledge of relevant DA, EU, ICH guidelines, initiatives, and regulations governing both Safety reporting and processing for clinical trial environments (including ICH/CIOMS, Clinical development methodology, and knowledge of Clinical Trial guidelines (GCP) and regulation) is essential.
Knowledge of Individual Case Safety Reports (ICSR) management processes including case receipt, case processing, medical review, and regulatory submission.
Strong knowledge of MedDRA and common safety database (ARGUS or ARISg).
Demonstrated technical, administrative, and project management capabilities.
Strong interpersonal, organizational, and workload planning skills along with excellent verbal and written communication skills.
Adaptable to changing priorities.
Self-motivated and able to work with minimal supervision in a fast-paced environment.
Proven ability to manage and lead a team through vision setting and constructive feedback.
Proficient computer skills, including Microsoft Word and Excel.
Skilled at negotiating with business partners or management and influencing senior-level leaders regarding matters of significance to the department or segments of the organization.
Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals

To protect the safety of our workforce, customers, and communities, the policy of the Company requires all employees and workers in the U.S. to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. All applicants seeking a role located in the U.S. must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.

Education & Experience:
MD, PharmD, or RN degree preferred
Bachelor’s degree in the life sciences or related will be considered with applicable job experience.
8 years or more in the Life Science industry with more than 6 years in Pharmacovigilance with prior oversight of Pharmacovigilance Operations.
Physical Requirements: OFFICE POSITION - While performing the duties of this job the employee is required to: •Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment •Specific vision abilities required by this job include close vision requirements due to computer work •Light to moderate lifting is required •Moderate noise (i.e. business office with computers, phone, and printers, light traffic). •Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional Physical Requirements:
No Additional Requirements
Blood/Fluid Exposure Risk: Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.

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