Associate Director - Pharmacovigilance

Integrated Resources, Inc

  • Cambridge, Massachusetts
  • 6 days ago
  • Contractor

Highlights

Approximately 5 – 10 bulleted task statements should be identified).SDEAs and PVAsImplement a scalable process for managing and tracking safety exchange agreements/documents (SDEAs, PVAs, Charters, SLAs, etc.)Review and provide input on SDEAs, PVAs, Charters, and associated Safety Agreement documentsCollaborate with the PV Compliance group to address and resolve compliance issues associated with SDEAs/PVAsPartner with key stakeholders to contribute to the development and maintenance of a global SDEA/PVA templateParticipate in meetings related to partner alliance and cross-program global operations as required. Provide strategic contributions to PV due diligence/business development activitiesProduct/company acquisition or licensingDue diligence activities for global PVDue diligence process documentsGeneralEscalate issues/problems to senior management as neededAny other tasks assigned by manager to assist in departmental activitiesEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:Bachelor's required.

Numbers & Facts

LocationCambridge, Massachusetts
Job TypeContractor

Description

Associate Director - PharmacovigilanceAssociate Director of PV Business Development oversees global strategic initiatives and operational aspects of business development. Primary responsibilities include but are not limited to:• Implement process improvement and increased efficiencies for global PV• Contribute to PV due diligence/business development activitiesACCOUNTABILITIES:(Describe the primary duties and responsibilities of the job. Approximately 5 – 10 bulleted task statements should be identified).SDEAs and PVAsImplement a scalable process for managing and tracking safety exchange agreements/documents (SDEAs, PVAs, Charters, SLAs, etc.)Review and provide input on SDEAs, PVAs, Charters, and associated Safety Agreement documentsCollaborate with the PV Compliance group to address and resolve compliance issues associated with SDEAs/PVAsPartner with key stakeholders to contribute to the development and maintenance of a global SDEA/PVA templateParticipate in meetings related to partner alliance and cross-program global operations as required.Identify and work to resolve issues in PV alliances/partnerships.Escalate issues in PV alliances to senior management as appropriate.Provide strategic contributions to PV due diligence/business development activitiesProduct/company acquisition or licensingDue diligence activities for global PVDue diligence process documentsGeneralEscalate issues/problems to senior management as neededAny other tasks assigned by manager to assist in departmental activitiesEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:Bachelor's required. Post-graduate degree or equivalent (Master's Degree/MBA) preferredExperience in, but not limited to, developing PV safety agreements, safety team charters, service level experienceExperience in and knowledge of due diligence for company acquisitions and/or licensing partnershipsProduct development including clinical safety experienceAbility to interact effectively with staff of multiple disciplines both within and outside the company both nationally and internationallyDemonstrated ability and experience leading high performing teams internally and cross functionally in a global highly matrixed and collaborative environmentAbility to proactively identify and anticipate risks associated with non-adherence to the regulationsStrong understanding and knowledge of the business areas both internally within the organization and touch points externallyExcellent time management skillsSelf-starter and strategic thinkerAble to lead teleconferences and meetingsProject management training and experienceProven ability to create and implement operational efficienciesExcellent oral and written communication skillsStrong relationship management skillsExpertise in clinical research and product safety activities in the pharmaceutical industryAbility to handle confidential information appropriatelyADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY):Minimum 8 years' experience in pharmaceutical/biotech industry with minimum 4 years' experience in Pharmacovigilance, clinical research, or alliance management roleAll your information will be kept confidential according to EEO guidelines.

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