Senior Specialist, Drug Safety

The Senior Pharmacovigilance Specialist (Sr PV Specialist) reports to the PV Associate Director and is responsible for the daily case management activities for assigned country(ies).

The PV Senior Specialist handles all PV activities, including aggregate and individual case safety report (ICSR) submissions to health authorities, compliance monitoring, and may serve as the PV contact with local stakeholders, headquarters (HQ), and local health authorities. The role involves collaborating with colleagues to ensure compliance with local laws and regulations, backing up colleagues, and adjusting schedules to prevent gaps in adverse event reporting and safety oversight.

Additional responsibilities (delegated / assigned by the Manager) may include PV intake, negotiation of local PV agreements, due diligence activities, audits and inspections, review of local initiatives for PV compliance, SOP management, local training, communication of safety issues, people development, and special projects, often working independently.

The Sr. Specialist may serve as a deputy / back-up Qualified Person for PV (QPPV), Local PV Contact, or Local Responsible PV Person as required by local PV legislation. If nominated as L-QPPV, commercial activities impacting L-QPPV are not permitted. In the absence of the Manager, the Sr. Specialist manages all day-to-day PV department activities and serves as back-up.

Required Education, Experience, and Skills

The candidate must hold a health, life science, or medical science degree or equivalent, be fluent in English (written and spoken), and proficient in the local language.

A minimum of 7 years of industry experience in pharmacovigilance is required.

Key competencies include advanced collaboration and partnering skills, strong communication skills, strategic thinking, project management, good business operations knowledge, and deep understanding of PV regulations and trends.

Additional Job Information

Must Haves :

At least 5 years of PV experience

Minimum 7 years of industry experience

Good to Haves :

Experience in PV operations

Who We Are :

Organon delivers innovative health solutions to improve lives, focusing on women's health, biosimilars, and diverse health portfolios. Our vision is to create a better, healthier everyday life for every woman. We value diversity and inclusivity in our hiring practices.

Search Firm Policy :

Organon LLC does not accept unsolicited assistance from search firms without a valid agreement. All submissions without an agreement are the company's property, and no fees are paid for referrals without a pre-existing contract. Please refrain from contacting us directly regarding this matter.

Additional Details :

Salary ranges vary by country; this is a regular position with no relocation support. Travel, visa sponsorship, and other logistical details are specified in the full job posting. Requisition ID : R

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