Job Description

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.

• 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.

Minimum education required:

• BS Degree preferably in Technical discipline (science, engineering) or Life Sciences (Biology, Chemistry, Nursing, Pharmacy) or related discipline

Required Experience and skills:

• 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

Preferred Experience and skills:

Five years' experience in Pharmacovigilance/Regulatory/CMC/Quality/Clinical

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

$122,800.00 - $193,300.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

Search Firm Representatives Please Read Carefully

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/26/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date: 09/26/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R309960