Associate Director, Drug Safety

Job Description

The Position

Under minimal guidance of the Executive Director- Head of Pharmacovigilance Agreement and Alliance Management, the incumbent independently assesses, writes, updates and maintains pharmacovigilance agreements. Participates in the negotiations of pharmacovigilance agreements with Organon Business Development Partners and Vendor Management. Represents Pharmacovigilance (PV) Agreements and Alliance Management in meetings with internal departments concerning business development agreement reporting responsibilities and processes.

Identifies and prioritizes workload to maintain compliance with departmental and regulatory reporting requirements.

Responsibilities

• Independently assesses, writes, updates, maintains, and stores pharmacovigilance agreements according to internal guidelines as well as company policies and standards.

• Independently organizes, conducts and/or facilitates meetings with business partners in the negotiation of pharmacovigilance agreements including global, regional, local and multi-country PV Agreements.

• Maintains, in collaboration with the Executive Director- Head of Pharmacovigilance Agreement (PVA) and Alliance Management, the internal guidelines for creating, updating and retention of business partner pharmacovigilance agreements.

• Responsible for ensuring that the transfer of legacy safety data to or from the business partner is appropriate and complete. Assesses 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

• Monitors and utilizes Business Partner and vendor information in related systems including Company repositories and the Business Development Lifecycle Management (BDLM) system.

• Collaborates with PV responsible staff and PV Responsible affiliates to ensure PV agreements are maintained and updated appropriately.

• Maintains in collaboration with the Executive Director- Head of Pharmacovigilance Agreements and Alliance Management, the internal guidelines for creating, updating and retention of business partner and vendor pharmacovigilance agreements.

• Ensures that the transfer of legacy data to or from the business partner is appropriate and complete. Assesses the requirements and liaises with Pharmacovigilance Operations team to ensure appropriate data and/or algorithms are updated based on the requirements of the agreement.

• Work in conjunction with all parties regarding assigned responsibilities related to PVA work to ensure responsibilities and all procedures are within compliance both with Health Authority regulations and Organon internal processes and standards.

Required Education, Experience and Skills

• A bachelor's degree is required.

• Deep subject matter expertise in pharmacovigilance and working with Business Partners, Vendors and pharmacovigilance agreements.

• Must have proven track record to be able to think critically, strategically, independently and problem solve.

• Ability to manage a large workload effectively and prioritize urgent business needs.

• Must have high level of motivation, drive, and demonstration of Organon leadership values.

• Excellent written and verbal communication skills including ability to write clearly and concisely.

• Excellent interpersonal skills in difficult situations.

• Driver of change and innovation.

• Ability to work seamlessly with all levels of personnel.

• Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.

• Excellent word processing, SharePoint, Excel, e-mail, and online meeting tool skills.

• A minimum of five years pharmaceutical experience or relevant professional experience.

• Experience with Veeva system.

Secondary Language(s) 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.

US and PR Residents Only

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Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

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.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1