Director Pharmacovigilance Physician
Director Pharmacovigilance Physician
Posted on :
03-02-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Title: Director Pharmacovigilance Physician
Job Location: Great Britain United Kingdom
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Director
Job Description Summary
The Director Pharmacovigilance Physician performs the signal detection and surveillance for products defined by the Head of PV. This involves providing scientific/clinical pharmacovigilance (PV) expertise with a focus on the identification evaluation and management of safety risks for specified PTC Therapeutics’ marketed and investigational products throughout the product lifecycle. He/she also contributes to the medical review of individual case safety reports and followup questions for Adverse Event reports received from clinical trials and postmarketing surveillance in compliance with Good Clinical Practice (GCP) company Standard Operating Procedures (SOPs) and other applicable guidelines and regulations as appropriate (e.g. 21 CFR Parts 312 and 314 and European Medicines Agency (EMA) Clinical Trials Directive and GVP modules).
The incumbent works crossfunctionally with internal departments and external resources on PV related issues.
The Director Pharmacovigilance Physician supports adherence to relevant regulatory requirements and company SOPs as appropriate.
Job Description
ESSENTIAL FUNCTIONS
Primary Duties/responsibilities
$250200 $314900. The base salary offered will be contingent on assessment of candidate education level background and experience relative to the requirements of the position they are being considered for as well as review of internal equity.
In addition to base salary PTC employees are also eligible for short and longterm incentives. All eligible employees may also enroll in PTC’s medical dental vision and retirement savings plans.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
EEO Statement
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals regardless of race color national origin gender age physical characteristics social origin disability religion family status pregnancy sexual orientation gender identity gender expression disability veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Click here to return to the careers page
The Director Pharmacovigilance Physician performs the signal detection and surveillance for products defined by the Head of PV. This involves providing scientific/clinical pharmacovigilance (PV) expertise with a focus on the identification evaluation and management of safety risks for specified PTC Therapeutics’ marketed and investigational products throughout the product lifecycle. He/she also contributes to the medical review of individual case safety reports and followup questions for Adverse Event reports received from clinical trials and postmarketing surveillance in compliance with Good Clinical Practice (GCP) company Standard Operating Procedures (SOPs) and other applicable guidelines and regulations as appropriate (e.g. 21 CFR Parts 312 and 314 and European Medicines Agency (EMA) Clinical Trials Directive and GVP modules).
The incumbent works crossfunctionally with internal departments and external resources on PV related issues.
The Director Pharmacovigilance Physician supports adherence to relevant regulatory requirements and company SOPs as appropriate.
Job Description
ESSENTIAL FUNCTIONS
Primary Duties/responsibilities
- Performs medical review of all Individual Case Safety Report from clinical trials and postmarketing sources.
- Contributes to reviews and/or approves safety aggregate reports (Periodic Safety Update Reports Development Safety Update Report Adhoc report Topic report Periodic Adverse Drug Evaluation Report etc.).
- Chairs the Safety Review Board for PTC investigational and marketed products periodically and on adhoc basis as needed.
- Performs monthly and quarterly signaling to identify validate and communicate signals and record in the appropriate documentation (e.g. signal tracker). Authors Risk Tracking Document and reviews/ contributes to the Risk Management Plans and Addendums.
- Provides oversight of PV CRO with regards to medical surveillance activities.
- Contributes to the development implementation and ongoing enhancement of safety surveillance processes and the associated SOPs.
- Collaborates with Regulatory Affairs to ensure appropriate reporting of PV information to regulatory agencies in a timely manner.
- Directs and provides key input for the review of new or ongoing safety documents that ensure compliance with domestic and international regulatory requirement that include but may not be limited to protocols study reports briefing books and questions from regulatory authorities.
- Provides input for the preparation and/or review of Reference Safety Information in Investigator Brochures (IBs) Core Data Sheet Local Label updates etc.
- Represents the PV function in development project teams and provides clinical guidance for pharmacovigilance activities through internal collaboration with Regulatory Affairs Biostatistics Clinical Operations/ Research Commercial and Quality Assurance (QA) and others as necessary.
- Provides input and/or review of all life cycle management submissions to worldwide health authorities for PTC marketed products.
- Provides support to health authority inspections FDA Adcom and other related activities for PTC investigational and marketed products.
- Performs other tasks and assignments as needed and specified by management.
- Represents PV and PTC at Regulatory Authority oral hearings and Advisory Committee meetings.
- Provide medical assistance to the EU QPPV as required (as per GVP Module I).
- Minimum level of education and years of relevant work experience.
- Medical degree e.g. MBBS MD or DO degree and a minimum of 8 years of progressively responsible related experience (minimum 7 years in a PV role) in a pharmaceutical biotechnology contract research organization (CRO) or related environment
- Special knowledge or skills needed and/or licenses or certificates required.
- Expert knowledge of relevant Food and Drug Administration (FDA) European Union (EU) and International Conference on Harmonisation (ICH) guidelines initiatives and regulations governing drug safety reporting and PV/DS in the conduct of clinical trials.
- Extensive working knowledge of medical terminology and principles of clinical assessment of AEs/SAEs in the pharmaceutical/biotechnology industry.
- Expertise in Medical Dictionary of Regulatory Activities (MedDRA) with relevance to AE/SAE coding.
- Expert in Risk Benefit Assessment and development of Risk mitigation strategies.
- Demonstrated handson experience identifying developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality (e.g. SAE reporting throughput rate).
- Demonstrated ability to identify opportunities to improve the PV reporting processes. This includes communicating recommended changes to the sponsor’s study management and site monitoring staff.
- Ability to influence without direct authority.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively as required in a fastpaced matrixed team environment consisting of internal and external team members.
- Analytical thinker with excellent problemsolving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning organization and time management skills including the ability to support and prioritize multiple projects.
- Special knowledge or skills and/or licenses or certificates preferred.
- Ability to review and interpret lab test results for clinical significance.
- Expertise in the use of Electronic Document Management System (eDMS) software.
- Expertise in World Health Organization’s Drug Dictionary (WHODD) with relevance to coding suspect drug and concomitant medications.
- Travel requirements
- 010%
$250200 $314900. The base salary offered will be contingent on assessment of candidate education level background and experience relative to the requirements of the position they are being considered for as well as review of internal equity.
In addition to base salary PTC employees are also eligible for short and longterm incentives. All eligible employees may also enroll in PTC’s medical dental vision and retirement savings plans.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
EEO Statement
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals regardless of race color national origin gender age physical characteristics social origin disability religion family status pregnancy sexual orientation gender identity gender expression disability veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Click here to return to the careers page
/jobs/view/322a3fc9ab9a2c5a2121cb723936cb2a
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
