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Pharmacovigilance Lead

Eingestellt von Synectics

Gesuchte Skills: Support

Projektbeschreibung

POSITION PURPOSE:
When our organization and another company enter into a licensing agreement on a product(s), the companies agree on each party's pharmacovigilance responsibilities on the licensing product(s). Safety information exchange processes are established between the companies to support their respective pharmacovigilance responsibilities.

RESPONSIBILITIES:
Supports colleagues in corporate/local licensing agreements, divestitures, and other business situations in which pharmacovigilance responsibilities are shared or transferred across corporations; Serves as Subject Matter Expert to support business development colleagues in drafting and reviewing pharmacovigilance sections within business agreements; Negotiate and finalize PVAs associated with licensing agreements executed by Corporate or Drug Safety Units; Reviews and revises existing PVAs; Communicates PVA defined terms to appropriate stakeholders to support individual PVA implementation and adherence; Represents organization to counterparts in contractual partner companies to communicate, escalate and resolve issues related to safety information exchange; Uses creative judgment to mitigate risk to the organization and to the customers who use the licensing products; Supporting PVA Licensing Team Lead and Strategy Leads for delivery of PVA (in/out licensed compounds) operational plan; Promotes stakeholders' awareness and understanding of PVA negotiation, drafting and execution processes; Collaborates with colleagues within the organization who are responsible for setting company policies and strategies on pharmacovigilance to proactively address changes to the regulations, company policies and procedures that impact pharmacovigilance alliances; Identifies and champions new approaches to create efficiencies in pharmacovigilance alliances; Positions the PVA group and all of the organization to achieve successful PV agreements and positive business relationships with corporate and local licensing parties. Works to identify and address barriers to achieving success; Supports regulatory inspections and internal audits with regard to PVA development and maintenance; Represents Licensing Team on cross-functional initiatives; Responsible for quality control of all individual work products originating from PVA Licensing team, including updates to the Global Regulatory System.

QUALIFICATIONS:
A scientific or technical degree is preferred; BS/BA with extended pharmaceutical industry experience; Strong background in project management; Understanding of GCP, ICH guidelines, pharmacovigilance regulations and processes, and clinical development process; International experience is valued; Understanding of the processes associated with pharmacovigilance, Clinical and Regulatory; Safety, Regulatory or Clinical development experience in order to have a thorough understanding of the processes associated with operational aspects; Excellent influencing, negotiation and collaboration skills and proven ability to achieve consensus across multi-disciplinary groups; Effective verbal and written communication skills; Considerable flexibility to remain effective in a changing regulatory and business environment; Creativity to identify solutions acceptable to a variety of stakeholders; Experience in contracts and outsourcing or licensing negotiation is preferred; Knowledge of project budgeting and understanding of project resource needs, ability to translate project requirements into effective contracts; Demonstrated strong interpersonal, leadership, and team player skills; Excellent presentation and communication skills.

SKILLS
FDA Regulations, Healthcare Law Compliance (HLC), Quality Assurance, Project Timelines, International Regulatory/Safety Regulations and Guidelines.

Synectics is an Equal Opportunity Employer.

Projektdetails

  • Einsatzort:

    Bridgewater, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Synectics