Associate Director, Pharmacovigilance Licensing
56 Livingston Ave Roseland, NJ 07068 US
Job Description
Target Pay Rate: 70-93.06/hr **salary will be commensurate with experience
Job Responsibilities:
Under minimal guidance of the Executive Director - Head of Pharmacovigilance Licensing, the incumbent independently assesses, writes, updates and maintains pharmacovigilance agreements and safety management plans. This includes exchange of adverse experience data with business partners. Represents Pharmacovigilance Licensing in meetings with internal departments concerning partner agreement reporting responsibilities and process flows. Identifies and prioritizes workload in order to maintain compliance with departmental and regulatory reporting requirements. . . This position will report to the Executive Director of PV Licensing within R&D Global Pharmacovigilance (PV) and Safety Science within PV Agreements and Alliance Management in the Research and Development organization. . . • Independently organizes, conducts and/or facilitates meetings with business partners and CRO partners in the negotiation of pharmacovigilance agreements. • Independently assesses, writes, updates, maintains, and stores PV agreements according to internal checklists and guidelines as well as company policies and standards. • Independently organizes, conducts and/or facilitates meetings with business partners, CRO partners and internal stakeholders for the implementation and maintainence activities in pharmacovigilance agreements. • Maintains, in collaboration with the Executive Director - Head of Pharmacovigilance Licensing, the internal guidelines for creating, updating and retention of business partner pharmacovigilance agreements. • Responsible for ensuring that the transfer of legacy data to or from the business partner is appropriate and complete. Assesses the requirements and liaises with Pharmacovigilance Operations team to ensure appropriate data and/or algorithms are updated appropriately based on the requirements of the agreement. • Collaborates with Executive Director - Head of Pharmacovigilance Licensing, to ensure training needs are assessed; creates and implements appropriate training as applicable in regards to new processes for each business agreement.
Qualifications:
- A bachelors degree is required
- A minimum of seven years pharmaceutical experience or relevant professional experience
- Deep subject matter expertise in pharmacovigilance
- Must have proven track record to be able to think critically, strategically, independently and problem solve
- Must have high level of motivation, drive, and demonstration of leadership values
- Excellent written and verbal communication skills including ability to write clearly and concisely
- Top notch interpersonal skills in difficult situations
- Driver of change and innovation
- Ability to work seamlessly with all levels of personnel
- Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations
- Excellent word processing, sharepoint, excel, e-mail, and online meeting tool skills
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