Associate Director, GRACS PV-PSM
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
Under minimal guidance of the Executive Director/Director/Associate Director, Pharmacovigilance (PV) Partner Strategy & Management (PV-PSM), the incumbent is responsible for PV management of all Company relationships, including business development partners, third-party vendors/suppliers, and emerging data sources. Responsible for independent negotiation and maintenance of business partner and vendor PV agreements and leadership of the Global Clinical Safety & Pharmacovigilance (GCS&PV) implementation activities for partner deals including but not limited to, acquisitions and divestiture deals. Responsible for the negotiation of safety management plans (SMPs) with Company CRO partners and oversight of the PV intake process and collaboration with International PV for management of local literature activities.
Responsibilities include but are not limited to:
Independently organizes, conducts and/or facilitates meetings with business development partners, CRO partners, third-party vendors/suppliers and internal stakeholders for the negotiation, implementation, and maintenance of PV agreements, PV plans, and SMPs.
Maintains, in collaboration with the Executive Director/Director/ Associate Director PV-PSM, the internal guidelines and procedures for creating, updating and retention of PV agreements, PV plans, and SMPs.
Oversight of due diligence, capability assessments, and compliance review of partners and third-party vendors/suppliers.
Responsible for ensuring that the transfer of safety data to or from the partner is appropriate and complete. Assesses the requirements and liaises within the Pharmacovigilance Operations team to ensure appropriate data and/or algorithms are updated appropriately based on the requirements of the agreement.
Responsible for implementation of Data Privacy agreements (DPA) and support activities required per the GRACS Privacy Annual Self-Assessment.
Collaborates with Executive Director/Director/Associate Director, PV-PSM to ensure training needs are assessed; creates and implements appropriate training as applicable in regard to new processes for each PV agreement.
End-to-end responsibility for the GCS&PV implementation and maintenance for all business development deals and third-party vendor/supplier agreements.
Act as point of PV contact for inspections and audits related to Company partnerships.
Interact closely with Legal, Business Development, Procurement, Human Health, and Alliance Management and other internal cross-functional stakeholders through the execution of strong processes for managing business development, third-party vendors/suppliers, and emerging data source deals as required to ensure consistency in PV policy implementation and processes globally.
Leads the screening and managing of global literature activities to maintain compliance with international pharmacovigilance and global health authority requirements.
Provide oversight of the PV intake process including collaborating with the Designated Point of Contact to ensure incoming information is received according to timelines and in agreement with PV local and global regulations.
The incumbent must be knowledgeable of global regulatory requirements at a general level and must be able to work with all levels of management within and outside of Global Regulatory Affairs and Clinical Safety (GRACS).
Interact closely with the system owner for the maintenance of the Business Development Lifecycle Management system.
Develop and implement cross-divisional PV policy to enable enterprise-wide activities to be conducted in compliant ways for our emerging data sources such as patient support programs and social media.
Develop and support processes that facilitate achievement of GCS&PV objectives.
The Associate Director may also have people management responsibilities related to oversight of team members in supporting opportunities in a similar manner as described above. Additionally, the incumbent will assume the responsibilities for employee development and management consistent with Company leadership principles.
May support some or all of the above responsibilities and/or any other project or perform any other task deemed appropriate by management.
BS Degree preferably in Technical discipline (science, engineering) or Life Sciences (Biology, Chemistry, Nursing, Pharmacy) or related discipline.
Skills and Experience:
A minimum of five years pharmaceutical experience or relevant professional experience.
Excellent written and verbal communication skills and negotiation skills including ability to write clearly and concisely, and the ability to facilitate meetings.
Strong conceptual and analytical thinking skills.
Excellent word processing, SharePoint excel, e-mail, and online meeting tool skills.
Demonstrated ability to manage multiple priorities.
Demonstrated ability to network, collaborate, and communicate across cultures, organizational levels and disciplines.
Demonstrated sensitivity and knowledge of cultural differences.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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Flexible Work Arrangements:Hybrid
Shift:1st - Day
Valid Driving License:No
Number of Openings:1