The Associate Director, Launch Excellence & Portfolio Capability Management will be a key member of the Global Launch Excellence and Portfolio Management team within Global Commercial Operations.
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Job Description
SUMMARY OF POSITION
The role will use technical expertise to
Support the setting of Pharmacovigilance and Product Quality Complaint cases in the UK
Support the Pharmacovigilance Manager in maintaining, developing and implementing Pharmacovigilance compliance procedures.
Priority is given to Pharmacovigilance case setting which must be completed to a high standard within short deadlines. This involves working with the technical and veterinary teams who gather the case information, to ensure that information gained is sufficient and to a high clinical standard to allow each Pharmacovigilance case to be fully assessed and coded within PV Works.
The role will also assist the current team of Pharmacovigilance Officers by giving technical support.
The role will assist the Pharmacovigilance Manager with the maintenance, development and implementation of Pharmacovigilance compliance procedures in line with internal and external guidance.
The successful candidate will be a vet, member of the RCVS ( Royal College of Veterinary Surgeons)
MAJOR ACTIVITIES AND RESPONSIBILITIES
- To enter data for pharmacovigilance cases in the appropriate system within the deadlines.
- To assess cases for VEDRA coding and final causality, with explanation of findings.
- Apply technical knowledge to improve pharmacovigilance case technical content, case quality and consistency
- To liaise with Competent Authorities as required
- To liaise with Vet advisers and the Technical Product Support Group to ensure accurate case data is available and to reconcile anomalies
- To work with Global colleagues to understand the Pharmacovigilance requirements for different products.
- Product Quality Complaints setting in PV Works
- To assist the Pharmacovigilance Manager with maintaining, developing and implementing Pharmacovigilance compliance procedures.
- To provide backup to the Pharmacovigilance manager and PQC DPOC to ensure compliance with procedure and deadlines as required.
- To give advice/training to Commercial, Pharmacovigilance and Technical product Support Group as required.
Major challenges of the role are:
- To source accurate data from practices and use technical knowledge to assess this when case setting.
- To liaise with global colleagues to discuss pharmacovigilance cases.
- To assess operational protocols and implement improvements.
- To ensure all cases are reported in the required timescale
- To prioritize work loads
Additional location(s) Compensation Information
Required Skills
Adverse Event Report, Compliance Monitoring, Data Analysis, Decision Making, Drug Safety Surveillance, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Regulatory Compliance, Regulatory Reporting, Risk Management, Veterinary Products, Veterinary ServicesPreferred 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
RegularRelocation
No relocationVISA Sponsorship
NoTravel Requirements
No Travel RequiredFlexible Work Arrangements
Not ApplicableShift: Not Indicated
Valid Driving License
NoHazardous Material(s)
N/AJob Posting End Date
10/28/2026About MSD
- Industry
- Pharma
- Founded
- 1891
- Employees
- 50,000–100,000
- Headquarters
- Rahway, USA
- Website
- msd.es
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