Job details
Job type full-time
Full job description
Job description
Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for covid-19 or intend to be vaccinated for covid-19 by november 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirementHired candidates who are not vaccinated by november 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.
Under minimal guidance of the executive director/director, pharmacovigilance licensing & business development, the incumbent independently assesses, writes, updates, and maintains pharmacovigilance business agreements, safety management plans and data privacy agreementsThis includes exchange of adverse experience data with business partners involved with our company as part of clinical trial investigations, supply agreements, co-marketing agreements, divestitures, and co-promotional agreementsNegotiates or participates in the negotiations of pharmacovigilance agreements, safety management plans, and data privacy agreements with company business partners and cro partnersSupports the data privacy stewards for global regulatory affairs and clinical safety (gracs).
Responsible for implementation of the new data privacy agreement (dpa) template/language for business partner pv agreements (pvas)Develops process to track and manage any related activities covered by the dpa.
Maintains, in collaboration with the executive director pharmacovigilance licensing & business development and associate vice-president regulatory compliance and partner operations (rcpo) the gracs privacy annual self-assessmentCollaborate with gracs functional areas on mitigation steps proposed to close any identified gaps.
Represents gracs in meetings and initiatives with the data privacy office including point person for privacy related communications, incidents, and trainingSupport the gracs functional areas with privacy compliance in new projects.
Ensures that it risk assessments for internal it systems; as well as, supplier hosted systems used by gracs hq are conducted.
Ensures that supplier privacy assessments for 3rd parties used by gracs hq are conducted.
Independently organizes, conducts and/or facilitates meetings with business partners, cro partners, and internal stakeholders for the negotiation of pharmacovigilance agreements, safety management plans, and data privacy agreements and any implementation/ maintenance activities
Independently assesses, writes, updates, maintains, and stores business agreements according to internal checklists and guidelines as well as company policies and standards.
Represents pharmacovigilance licensing in meetings with internal departments concerning partner agreement reporting responsibilities and process flowsIdentifies and prioritizes workload in order to maintain compliance with departmental and regulatory reporting requirements.
Maintains, in collaboration with the executive director/director pharmacovigilance licensing & business development, the internal guidelines for creating, updating and retention of business partner pharmacovigilance agreements and safety management plans.
Responsible for ensuring that the transfer of legacy data to or from the business partner is appropriate and completeAssesses 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/director, pharmacovigilance licensing and business development to ensure training needs are assessed; creates and implements appropriate training as applicable regarding new processes for each business agreement.
End to end responsibility for the global clinical safety & pharmacovigilance implementation and maintenance for all business development deals including mergers/acquisitions and divestitures.
Act as point of contact for inspections and audits related to business partnerships and data privacy itemsInteract closely with legal, business development, and alliance management through the execution of strong processes for managing business development deals in the pre-execution space including due diligence, resource analysis, contractual provisions by deal type, and communications.
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 gracs.
Interact closely with the business system owner for the maintenance of the business development lifecycle management system used for extraction of key fields from executed contracts and accessed for partner notification of signal detection, ccds updates, aggregate report review and receipt.
Identify and prioritize agreements in order to maintain compliance with worldwide regulatory requirements.
Education:
Bs/ba degree: preferably in life sciences (biology, chemistry, nursing, pharmacy) or related discipline
Required experience:
A minimum of seven years pharmaceutical experience, privacy experience, information risk management, working with or within a healthcare/consumer care industry project management, 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 ability to make effective and timely decisions
Demonstrated sensitivity and knowledge of cultural differences
Preferred experience:
Five years of experience in pharmacovigilance/regulatory/cmc/quality/clinical/privacy/information risk management
We are a research-driven biopharmaceutical companyOur mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our worldWe 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., kenilworth, new jersey, usa in the united states and canada and msd everywhere elseFor more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world`s most challenging diseasesToday, 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 …
In a world of rapid innovation, we seek brave inventors who want to make an impact in all aspects of our business, enabling breakthroughs that will affect generations to comeWe encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.
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 packageTo discuss in more detail, please contact your hrbp or talent acquisition advisor.
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 capabilitiesPlease click here if you need an accommodation during the application or hiring process.
Pay transparency nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people togetherThe fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environmentWe encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectivelyWe are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search firm representatives please read carefully
Merck & co., inc., kenilworth, nj, usa, also known as merck sharp & dohme corp., kenilworth, nj, usa, does not accept unsolicited assistance from search firms for employment opportunitiesAll 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 companyNo 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 placeWhere agency agreements are in place, introductions are position specificPlease, no phone calls or emails.
Employee status:
Regular
Relocation:
No relocation
Visa sponsorship:
No
Travel requirements:
10%
Flexible work arrangements:
Remote work
Shift:
Valid driving license:
Hazardous material(s):
Number of openings:
1
Requisition id: r141493
