Specialist, Drug Safety

Job Description

The Position

The PV Specialist reports to the PV Associate Director and is responsible for PV activities (as delegated / assigned by their manager) which may include but are not limited to : PV Intake activities (including conducting reconciliation and follow-up), Individual case safety report (ICSR) and aggregate submissions, supporting audits and inspections and related readiness activities, authoring local SOPs, local training, escalation of safety issues, and archiving and is able to perform these tasks with minimal supervision.

PV Specialist may undertake other additional activities including projects with oversight by their manager.

Required Education, Experience and Skills :

• The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken) while proficient in local language.
• He / she should have a minimum 3 years of PV experience in pharma industry.
• He / she must have a general knowledge of PV regulations within his / her assigned country and be an expert in PV processes / activities.
• Collaboration and Partnering : Demonstrates advanced ability to work in partnership with others (internally and externally) to accomplish quality goals.
• Communication Skills : Demonstrates strong communications skills to convey and receive information in English and local language.  Demonstrates advanced oral and written communications skills. Demonstrates good presentation skills.
• Problem Solving :  Demonstrates skills in problem solving using creative thinking, gathers data from appropriate stakeholders and ability to respond to new complex situations and influence organization direction.
• Strategic Thinking :  Demonstrates strong skills to drive change that enhances processes within the company or cross-functionally within MRL / MMD / GHH that improve quality and / or add value to the business.
• Project Management :  Demonstrates strong skills in the ability to organize work efforts, prioritize tasks and utilize appropriate resources to support PV and RA activities in accordance with timelines and appropriate regulations.
• Regulatory and Compliance Management : Demonstrates knowledge of PV regulations and regulatory trends.

Secondary Job Description

Must haves : 2-3년 이상의 PV 경력

Good to haves : 3-5년 이상의 제약 회사 근무 경험

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.

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

Flexible Work Arrangements :

Shift :

Valid Driving License :

Hazardous Material(s) :

Number of Openings :