The Position

The Senior Drug Safety Specialist is responsible for all assigned pharmacovigilance activities and may serve as the point of contact with local stakeholders, headquarters and the local health authority. Reporting to the Associate Director Drug Safety based in Melbourne, Australia, the Senior Drug Safety Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and safety oversight.
This newly created role is a 12-month fixed term contract to assist in the standing up of our Asia Pacific affiliate Pharmacovigilance unit. It is a remote opportunity and can be based in any of our Asia Pacific locations - Australia, India, Malaysia, Singapore, Philippines, Hong Kong, Vietnam, Thailand, Taiwan, and Indonesia. This role also has the potential opportunity to become permanent.
Responsibilities include but are not limited to:

• Responsible for execution of local and unit PV processes and activities in alignment with PV systems and their associated Quality Management System.
  
• Manage PV requirements for Patient Support Programs (PSP), Market Research vendor(s) and other programs related activities, as applicable.
  
• Ensuring PV language is included in agreements, liaising with business partners and vendors as required.
  
• Assist in developing local and unit procedures, to ensure quality PV data.
  
• Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
  
• Manage the training of PV staff (including maintenance of the local and unit training matrix) and supports the required training of internal and external stakeholders.
  

Experience & Qualifications:

• Educational background in medical, life science or equivalent
  
• 3+ years’ experience in pharmacovigilance
  
• Experience in management of Pharmacovigilance Programs such as Market Research, Patient Support Program & Contract Management (advantageous)
  

Skills:

• Strong communication, problem solving & decision-making ability
  
• Strategic thinking
  
• Previous experience in project management
  
• Business Operations/Knowledge of Field
  
• Regulatory and Compliance Management
  
• Fluent in English (written & spoken)
  

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:
Temporary (Fixed Term)
Relocation:
No relocation
VISA Sponsorship:
No
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
Requisition ID:R529614