Senior Specialist, Pharmacovigilance Agreement Operations

Job Description

The Position

• Responsible for PV Agreement related tasks involving Business Partners.
• Identifies and prioritizes workload to maintain compliance with departmental and regulatory reporting requirements.
  
  

Responsibilities

• Enter Pharmacovigilance Agreements and Safety Management Plan (SMP) data into the Veeva (Business Development Lifecycle Management [BDLM]) database and other related Partner information as required.
• Performs a random sample of the BDLM data against the information in the source documents of the Agreements on a set timeframe (i.e. quarterly) to confirm updates are being made to BDLM and information in BDLM metadata fields are accurate. This activity will not be performed by the same individual who entered the information into BDLM.
• Manage and train PV Agreement resources/contractors on all job activities to provide consistent coverage of team responsibilities.
• Tracking, collating and managing performance metric information from stakeholders/Partners.
• Using standard templates drafts initial version of Business Partners PV Agreement documents in MS Word.
• Utilize the bilingual templates as needed.
• Sends initial drafts to PV agreement owners for review and edits.
• Works with PV agreement owners to finalize the agreement.
• Sends regular reminders to PV agreement owners to ensure agreements are finalized in a reasonable timeframe. Uploads the final MS Word document into BDLM and routes for approval.
• Maintains tracker of various agreements under review to ensure work is completed expeditiously.
• Assists PV agreement owners with annual maintenance activities including annual reminder and aggregate report notices to Business Partners and annual Adverse Event training/refreshers
• Collaborates with PV staff and affiliates to ensure PV agreements are maintained and updated appropriately.
• Working to maintain and operationalize the BDLM system including maintaining essential checklists/PV Agreement documents and reference guides.
  
  

Required Education, Experience And Skills

• Bachelors Degree is required
• Healthcare or life sciences background, with a good understanding of pharmacovigilance principles and practices.
• Previous experience of 3+ years in the pharmacovigilance field specifically in PV agreement and licensing.
• Experience with Veeva Vault
• Priority organization and task management
• Leadership and influence of indirect teams
• Strategic planning.
• Project management with agile methodologies,
• Demonstrable communication and presentation skills to broad, small, executive, operational and related audiences.
• Interpersonal skills to interact with cross-functional team members
• Strong drive, proactivity, and willingness to learn and contribute
• Ability to multi-task with proven submission planning capabilities including managing dynamic timelines, interacting and negotiating with others, collaboration skill and excellent follow-up ability.
• Excellent oral and written communication skills to manage interactions with colleagues within and outside the department to co-ordinate the regulatory submission for a timely delivery.
• Strong listening skills.
• Superior attentiveness to detail.
• Effectively work with and communicate to key stakeholders.
• Flexibility in responding to changing priorities or dealing with unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Ability to prioritize tasks to meet deadlines and collaborate with a team when help is needed.
• Ability to identify problems and work with team to formulate a potential course of action.
• Ability to perform assigned tasks swiftly and accurately.
• Good interpersonal and communication skills (in English regional languages)
• Cultural sensitivities and experience in handling diverse cultures
  
  

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Search Firm Representatives Please Read Carefully

Organon LLC, 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.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status

Regular

Relocation:

No relocation

VISA Sponsorship

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Shift

Flexible Work Arrangements:

Valid Driving License

Hazardous Material(s):

Number Of Openings

1

Requisition ID:R530322