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Senior Specialist, Drug Safety

2+ years
Not Disclosed
10 Oct. 16, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

The Position

This position can be 100% remote within the Asia Pacific region.

The Senior Drug Safety Specialist will oversee all assigned pharmacovigilance activities and serve as the primary contact for local stakeholders, headquarters, and health authorities. Reporting to the Associate Director of Drug Safety based in Melbourne, Australia, the Specialist will collaborate with colleagues to ensure compliance with local laws and regulations, including covering for colleagues to maintain continuous adverse event reporting and safety oversight.

This newly established role is a 12-month fixed-term contract aimed at supporting the launch of our Asia Pacific Pharmacovigilance unit. There is potential for this position to become permanent.

Responsibilities include but are not limited to:

  • Execute local and unit pharmacovigilance processes in alignment with PV systems and Quality Management System.
  • Manage PV requirements for Patient Support Programs (PSP), Market Research vendors, and other related activities.
  • Ensure PV language is included in agreements and liaise with business partners and vendors as necessary.
  • Assist in developing local and unit procedures to ensure quality pharmacovigilance data.
  • Proactively identify procedural gaps and challenges, implementing solutions in collaboration with stakeholders.
  • Manage the training of PV staff, including maintaining the local and unit training matrix, and support training for internal and external stakeholders.

Experience & Qualifications:

  • Educational background in medical, life sciences, or a related field.
  • 3+ years of experience in pharmacovigilance.
  • Experience managing Pharmacovigilance Programs, including Market Research, Patient Support Programs, and Contract Management (preferred).

Skills:

  • Strong communication, problem-solving, and decision-making abilities.
  • Strategic thinking capability.
  • Previous project management experience.
  • Knowledge of business operations and compliance management.
  • Fluent in English (written and spoken).

Who We Are:

Organon delivers innovative health solutions that enable people to live their best lives. As a $6.5 billion global healthcare company, we are committed to making a meaningful difference for women, their families, and their communities. Our portfolio is growing as we invest in the unmet needs of Women’s Health and expand access to trusted 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 diverse backgrounds and are committed to creating an inclusive environment for all 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.

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.