Sr. Specialist PV/QPPV - Egypt

Job Description
Organon is a Women's Health Company that believes in a better and healthier
every day for every woman! We are a passionate, global community of thousands
dedicated to redefining the future of women's health. Our mission is to
deliver impactful medicines and solutions for a healthier every day. But what
really makes it work at Organon is our people.
We're looking for real, passionate team players, curious innovators, forward
thinkers, empowered by the idea of shaping their career, and ready to bring
their fire to embrace change and the opportunities it brings for progress.
At Organon, you'll get to enjoy the best of both worlds: the open, agile,
collaborative culture of a start-up, and operating at the scale of a Fortune
‎500 company with an international footprint that serves people in more than
‎140 markets.
It's going to be an exciting future--come be a part of it!
Responsibilities:
Serves as the back-up PV Responsible person/QPPV as required per local PV
legislation. Oversees all daily PV processes and activities within the
countries covered by the country operation as required. Responsible for
execution of local PV processes and activities in alignment with PV systems
and their associated Quality Management System, following department SOPs,
company Policies and Procedures and country legislation Performs
reconciliation activities for PV cases received from local operating units
(e.g., Designated Point of Contact, Medical Information, etc.) and contractual
partners (as applicable) and processes the reports in accordance to local
procedures/ PV legislations
Provides support for Patient Support Programs (PSP) and/or Market Research
vendor(s) related activities, as applicable Files, stores and archives safety-
related and regulatory data and documentation in accordance with department
and company policies and local requirements.
Acts in full compliance with global and local SOPs and reports any deviations
or compliance concerns immediately and assists in preparing necessary
corrective actions and preventative actions (CAPAs) locally for non-compliance
issues.
Serves as SME and supports local PV audits and inspections including readiness
activities and supports other audits/inspections including the development of
CAPAs in response to findings/observations. Participates in and supports
audits of contractual partners/vendors as necessary. May be trained and
assigned responsibility to conduct qualification and ongoing audits of vendors
and perform due diligence activities for local country licensing agreements.
Assists in developing local procedures (in compliance with regional and global
standards) for the department, to ensure quality PV data and evaluates
processes for potential improvement in efficiency and effectiveness.
Develops and maintains local PV controlled documents (i.e., SOPs, training
materials) ensuring that they are kept current Proactively identifies
procedural gaps and challenges and implements solutions in collaboration with
all affected stakeholders.
Leads the training of PV staff (including maintenance of the local training
matrix and onboarding plans) and supports the required training of the local
company staff, distributors, vendors, business partners including training
documentation.
May be assigned responsible for ensuring PV language is included in local
agreements, liaising with business partner as required, and ensuring
maintenance of BDLM with respect to local and regional contracts. May be
assigned responsible for ensuring appropriate implementation and oversight of
Risk Minimization Measures and ARMMs locally Serve as the point of contact for
the local Health Authority for PV related questions from the Health
Authorities (when assigned) Liaises with the local business units to keep them
apprised of safety activities and provide input on strategic decisions (i.e.,
new clinical trials, product launches, etc.) with Management oversight.
Qualifications & Skills:
* Preferred Pharma Degree, health, life sciences or medical sciences.
* At least ‎5 years experience in this field
* Pharmaceutical or health industry
* Must be familiar with Egypt PV regulations
* Preferred to have experience in Libya, Sudan and Yemen markets
* Mature experience in management and supervising different individuals / people management
* Strong cross-functional collaboration with stakeholders
* Excellent English and communication skills
* Time management Skills
* Flexible to travel when needed

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.
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.
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:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
‎1

Requisition ID: R510925