Job Detail

JOB DESCRIPTION

Job Description

We are currently looking for The Pharmacovigilance (PV) and Regulatory Affairs (RA) Cluster/Sub-Regional Lead (Director) who will responsible for managing the PV and RA staff and processes in their sub-region and may also be responsible for managing the PV and RA staff and processes in their home country.

In this role you will be responsible for ensuring compliance with PV and RA processes and regulations, company policies and procedures, establishing best practices, and representing the company for any safety, regulatory or compliance issues. You will be also responsible for interfacing with PV headquarters, RA Therapeutic Leads, labeling, business process leads, Global Medical Affairs (GMA), marketing teams, and other business units to ensure alignment on issues impacting PV and RA activities.

Main Responsibilities:

• Define the strategic direction of PV and RA and develop short, medium and long-term action plans to fulfil the strategy




• Ensure the PV and RA teams are aligned to the strategy and are supportive of the company’s global and regional objectives




• Be accountable for the planning and execution of PV and RA strategies for medicinal products and medical devices




• Be responsible for delivery of cross-divisional projects, by leading the PV and RA teams to collaborate with other functions to ensure that global and regional objectives are met




• Responsible for enabling collaborative relationships across all divisions including Managing Directors, Human Resources, Finance, Quality, GMA and Manufacturing colleagues, if present in countries, to ensure commitments and objectives are met




• Responsible for liaising between country and HQ to apply global standards and metrics




• Responsible for the recruitment, development and performance management

Skills and Experienced:

• Health, life science, or medical science degree or equivalent by education / experience




• Minimum of 7 years of industry experience in pharmacovigilance and /or regulatory affairs




• Minimum 5 years of supervisory experience and working with and/or collaborating across multiple countries




• Experience interacting with internal auditors and health authority Inspectors




• Strong leadership, communication, decision making, and problem-solving skills




• Fluent in English (written and spoken)




• Ability to travel within the region and globally is required

 #NewCo

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.

At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion.

At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.

We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R89996