Pharmacovigilance (PV) Country Lead Portugal (Associate Director)

Job Description

An amazing opportunity has arisen for a Pharmacovigilance (PV) Country Lead Portugal (Associate Director). In this role you will be responsible for a range of assigned PV activities and will be empowered to work and make decisions independently within your delegated remit. You will ensure that all PV activities under your oversight are executed in accordance with applicable regulations local legislation and internal company policies and procedures.

In this role you will be designated Local PV Contact / Local Responsible PV person as required by local PV legislation. You will work closely with internal and external stakeholders and lead a team who reports into your role you will be reporting into the PV Cluster Lead Mid-Europe.

What you will do

Bring energy knowledge innovation and leadership to carry out the following:

• Oversee and execute local PV processes and activities in collaboration with internal functions and external partners ensuring alignment with local legislation and local/regional/global procedures including management of local PV agreements due diligence PSMP implementation training and safety communication.
• Lead daytoday adverse event case management (e.g. case triage translations followup) in accordance with PV procedures and country regulations and act as local PV subject matter expert on relevant regulations processes and procedures.
• Support audits and inspections (local PV business partner and vendor) including readiness activities participation in issue management/compliance activities and contribution to CAPA development and local corrective actions.
• Develop maintain and implement local PV procedures and controlled documents (e.g. SOPs training materials Pharmacovigilance Documents local RMPs) and oversee local literature screening risk management activities and business continuity plans in line with company and regulatory requirements.
• Monitor Health Authority websites for safety issues alerts and PV requirements; liaise with local business units; represent PV in crossfunctional and external forums; participate in local committees/councils and special projects; and where applicable manage direct reports including recruitment development and performance management.
• Manage and develop the local PV team.

What skills you will need

In order to excel in this role you will more than likely have:

• Language skills: native in Portuguese and excellent in English (both written and verbal)
• Solid experience in pharmacovigilance within the pharmaceutical or biotechnology industry with proven responsibility for local PV activities.
• Strong knowledge of local PV legislation regulations and guidelines and demonstrated ability to interpret and operationalize PV requirements.
• Handson expertise in adverse event case management aggregate safety reporting risk management (including RMPs and Risk Minimization Measures) and local literature surveillance.
• Experience supporting or leading PV audits and inspections including preparation conduct issue management and development/implementation of CAPAs.
• Proven ability to develop implement and maintain PV procedures and controlled documents and to ensure highquality PV data and documentation.
• Strong collaboration and communication skills with the ability to work effectively with crossfunctional teams business partners vendors Health Authorities and external industry forums.
• Demonstrated organizational and project management skills with the ability to manage multiple priorities special projects and business continuity activities in a fastpaced environment.
• Commitment to continuous learning completion of required trainings and high standards of compliance integrity and accountability in all PV activities.

Why Join Us We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs. We are proud to be a company that embraces the value of bringing talented and committed people together. The fastest way to breakthrough innovation is when varied ideas come together in an inclusive environment.

So if you are ready to...

contribute your pharmacovigilance expertise leadership and passion for patient safety in a highly visible Associate Director role please apply today.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.