Associate Director, GRACS PV-PSM

Job Description

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.

Education:

• 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.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R212934