Pharmacovigilance Specialist

at  Merck

Job Description

POSITION OVERVIEW

The Pharmacovigilance (PV) Specialist is responsible for all PV activities and 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 drug safety oversight.
The PV Specialist will be also responsible for other activities (as delegated/assigned by their Manager) which may include but are not limited to review of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, authoring/reviewing SOPs, training, communication of safety issues. The PV specialist may serve as Local Responsible PV person as required per local PV legislation.
The PV specialist may also participate in certain local Regulatory Affairs (RA) activities where needed.

BACKGROUND REQUIREMENTS:

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(s).
We expect a minimum of 2 years of industry experience in pharmacovigilance. Our new colleague must have strong communication and time management skills and can work independently with minimal supervision.

SKILLS:

Primary skills include but are not limited to:
1. Collaboration and Partnering: Demonstrates ability to work in partnership with others (internally and externally) to accomplish quality goals.
2. Communication Skills: Demonstrates good communications skills to convey and receive information in English and local language(s).
3. Problem Solving: Demonstrates good skills in problem solving using creative thinking.
4. Project Management: Demonstrates good skills in the ability to organize work efforts, prioritize tasks and utilize appropriate resources to support PV activities in accordance with timelines and appropriate regulations.
5. Decision Making: Demonstrates strong skills to utilize knowledge, networks and data to make rapid and appropriate decisions with some management oversight and to determine when escalation of issues is necessary.
6. Regulatory and Compliance Management: Demonstrates knowledge of PV regulations and regulatory trends.

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.
If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

Please refer the Job description for details